FDA 510(k) and De Novo database for PPG and wearable devices
Every FDA clearance and De Novo grant we track for pulse oximeters, smartwatch ECG and irregular-rhythm features, wearable blood pressure, sleep apnea and remote vital-sign monitors. Filter by pathway, company, product code, year, claim, sensor and prescription status, then copy the link to share that exact view.
openFDA data through Oct 26, 2026. Last synced Nov 9, 2026. K254226 was added by hand from FDA's 510(k) database on Nov 9, 2026 because openFDA had not loaded it yet.
459
FDA records
443
510(k) clearances
16
De Novo grants
166
companies
34
product codes
All 459 records
Newest decisions first. Open a number for its facts, the indications and predicates parsed from FDA's documents, and related records. The latest decisions are K254226 (PulseAI, Oct 27, 2026), K260676 (Masimo, Oct 14, 2026), K260490 (Shenzhen Ninenovo Technology, Oct 2, 2026), K254297 (Tempus AI, Sep 25, 2026) and K254240 (Neko Health, Sep 22, 2026). The companies with the most records are Masimo (102), Beijing Choice Electronic Technology (20), Itamar (17).
| FDA number | Device and company | Decision | Product code | Rx / OTC | FDA source |
|---|---|---|---|---|---|
| K254226 | PulseAPI SmartWatchPulseAI | 510(k) · cleared | DQK | Unknown | FDA record · PDF |
| K260676 | Radius VSM and AccessoriesMasimo | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K260490 | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14)Shenzhen Ninenovo Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K254297 | Tempus ECG-MRTempus AI | 510(k) · cleared | SBQ | Unknown | FDA record · PDF |
| K254240 | Echo-2Neko Health | 510(k) · cleared | QOK | Unknown | FDA record · PDF |
| K254000 | Happy Health Blood Pressure MonitorHappy Health | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K253417 | Masimo Root Monitoring SystemMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K254042 | WatchPAT SWItamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K261011 | Sleep Apnea Feature (v2.0)Samsung | 510(k) · cleared | QZW | OTC | FDA record · PDF |
| K253694 | Natural CyclesNatural Cycles | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K261569 | UbiqVue 2AYe Cardiac System (UX2253)LifeSignals | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K253148 | RX-1 SleepVivaQuant (dba Rhythm Express) | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K254169 | SmartSpectra Vital Signs Monitor 1.0Presage | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K253650 | Anura Mobile Core SDK (M1)Nuralogix | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K260332 | EchoNextPathwai | 510(k) · cleared | QXO | Unknown | FDA record · PDF |
| K254209 | Radius VSM and AccessoriesMasimo | 510(k) · cleared | MHX | Unknown | FDA record |
| K260066 | PanopticAI Vital Signs (1.6.1-22)PanopticAI | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K251200 | Vital SignsOxehealth | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K252589 | Corvair MonzaAliveCor | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K252981 | EmbraceMiniEmpatica | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)Huinno | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K252474 | Withings BeamO (SCT02)Withings | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| DEN240080 | Biolinq Shine Autonomous Time-in-Range MicrosensorBiolinq | De Novo · granted | SFU | Unknown | FDA record · PDF |
| K250507 | Hypertension Notification Feature (HTNF)Apple | 510(k) · cleared | SFR | OTC | FDA record · PDF |
| K250460 | WatchPAT400 (WP400)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K250874 | SunriseSunrise | 510(k) · cleared | QRS | Unknown | FDA record · PDF |
| K243687 | Vital SignsOxehealth | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K251574 | Sleep WatchAmbulatory Monitoring | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort)CAIRE | 510(k) · cleared | CAW | Unknown | FDA record · PDF |
| K250415 | G0 Blood Pressure Monitoring System (G0)Aktiia / Hilo | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K242224 | Happy Health Home Sleep TestHappy Health | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K240795 | Withings ECG AppWithings | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)Mindset Medical | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K250757 | Radius VSM and AccessoriesMasimo | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K242518 | Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences | 510(k) · cleared | QAQ | Unknown | FDA record · PDF |
| K243513 | DCM (PW-DCM)Pneumowave | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)FaceHeart | 510(k) · cleared | BZQ | Unknown | FDA record · PDF |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0)Whoop | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K243305 | Masimo W1Masimo | 510(k) · cleared | DPS | OTC | FDA record · PDF |
| K250561 | Natural CyclesNatural Cycles | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B)Wellue / Viatom | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K242967 | Loss of Pulse DetectionFitbit | 510(k) · cleared | SDY | OTC | FDA record · PDF |
| K243778 | Body Temperature Software (BTS)Fitbit | 510(k) · cleared | QZA | OTC | FDA record · PDF |
| K241066 | BB-613-BPMBiobeat | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K240890 | PanopticAI Vital SignsPanopticAI | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K241090 | Evie Med RingMovano | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBHShenzhen Smallsignal Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K241633 | Informed Vital Core Application (IVC App)Mindset Medical | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K211498 | Nonin OTC Pulse Oximeter Model 3250Nonin Medical | 510(k) · cleared | OLK | Rx | FDA record · PDF |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550)LifeSignals | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K234110 | Belun Ring BLR-200 (BLR-200)Belun | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))Omron Healthcare | De Novo · granted | QXY | OTC | FDA record · PDF |
| K241101 | BioButton SystemBioIntelliSense | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K240236 | Happy Ring Health Monitoring SystemHappy Health | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K240929 | Sleep Apnea Notification Feature (SANF)Apple | 510(k) · cleared | QZW | OTC | FDA record · PDF |
| K231667 | Withings Sleep RxWithings | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K240229 | Masimo W1Masimo | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K240909 | Samsung ECG App v 1.3 (ECG)Samsung | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)Largan Medical | 510(k) · cleared | MNR | Unknown | FDA record |
| K240756 | AITRICS-VCAitrics | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K240558 | NAVOYCDSAlgodx | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K241006 | Natural CyclesNatural Cycles | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K233549 | Tempus ECG-AFTempus AI | 510(k) · cleared | SBQ | Unknown | FDA record · PDF |
| K233987 | VERABANDArbor Medical Innovations | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K231010 | CorvairAliveCor | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K232035 | ImpalaAliveCor | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K232804 | FibriCheckQompium / FibriCheck | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K234021 | Masimo StorkMasimo | 510(k) · cleared | QYU | OTC | FDA record · PDF |
| K232445 | CSF-4 (CSF-4)Cardiac Sense | 510(k) · cleared | DPS | Rx | FDA record · PDF |
| K233618 | Oxevision Sleep DeviceOxehealth | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse OGE Medical Systems Information Technologies | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| DEN230041 | Sleep Apnea FeatureSamsung | De Novo · granted | QZW | OTC | FDA record · PDF |
| K214115 | MightySat -OTCMasimo | 510(k) · cleared | OLK | OTC | FDA record · PDF |
| DEN230050 | Body Temperature Software (BTS)Fitbit | De Novo · granted | QZA | OTC | FDA record · PDF |
| K223721 | Masimo StorkMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K232053 | SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K230587 | Wrist Pulse OximeterBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K232512 | Masimo W1Masimo | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| DEN220091 | Dream SockOwlet | De Novo · granted | QYU | OTC | FDA record · PDF |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| DEN200076 | ORiMasimo | De Novo · granted | QWE | Unknown | FDA record · PDF |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK)FaceHeart | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K221361 | circul pro RingBodimetrics | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K231274 | Natural CyclesNatural Cycles | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K230812 | Withings Scan Monitor 2.0Withings | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K223573 | Onera Sleep Test System (Onera STS)Onera | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), PortraitGE Medical Systems Information Technologies | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| DEN230003 | Viz HCMViz.ai | De Novo · granted | QXO | Unknown | FDA record · PDF |
| K231173 | Irregular Rhythm Notification Feature (IRNF)Apple | 510(k) · cleared | QDB | OTC | FDA record · PDF |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K222597 | BabySat 3Owlet | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K230386 | SpassageQSpass | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K230057 | Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences | 510(k) · cleared | QAQ | Unknown | FDA record · PDF |
| K223498 | Radius VSM and AccessoriesMasimo | 510(k) · cleared | MHX | Rx | FDA record · PDF |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K213676 | Masimo Rad-G with TemperatureMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| DEN200011 | Masimo SafetyNetMasimo | De Novo · granted | QVT | Unknown | FDA record · PDF |
| K212161 | Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K222579 | Belun Sleep System BLS-100Belun | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K221774 | Garmin ECG AppGarmin | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K213423 | T3 Platform softwareEtiometry | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K221260 | CSF-3Cardiac Sense | 510(k) · cleared | DPS | Rx | FDA record · PDF |
| K223675 | WatchPAT ONE (WP1)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K213430 | Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K222010 | Biobeat Platform-2 and BB-613WP PatchBiobeat | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K222262 | SunriseSunrise | 510(k) · cleared | QRS | Rx | FDA record · PDF |
| K221282 | Empatica Health Monitoring PlatformEmpatica | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K220351 | Polso WatchChronisense Medical | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K203812 | Oxyfit Pulse OximeterWellue / Viatom | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K222842 | V-Patch Cardiac MonitorShandong Corecare Technology | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K222331 | WatchPAT300 (WP300)Itamar | 510(k) · cleared | MNR | Rx | FDA record · PDF |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHbMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences | 510(k) · cleared | DXH | Rx | FDA record · PDF |
| K220095 | ANNE SleepSibel | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K213360 | SleepCheckRxResapp Health | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K213971 | Atrial Fibrillation History FeatureApple | 510(k) · cleared | QDB | OTC | FDA record · PDF |
| K220350 | KardiaMobile 6LAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K201302 | LiveOneLiveMetric | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K220899 | Oxehealth Vital SignsOxehealth | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K212372 | Fitbit Irregular Rhythm NotificationsFitbit | 510(k) · cleared | QDB | OTC | FDA record · PDF |
| K210593 | Onera Sleep Test System (Onera STS)Onera | 510(k) · cleared | MNR | Rx | FDA record · PDF |
| K212153 | Biobeat Platform, BB-613WP PatchBiobeat | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K203839 | WatchPAT200U (WP200U)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| DEN210015 | Sunrise Sleep Disorder Diagnostic AidSunrise | De Novo · granted | QRS | Unknown | FDA record · PDF |
| K211668 | KardiaMobile CardAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K212516 | IRNF AppApple | 510(k) · cleared | QDB | OTC | FDA record · PDF |
| K211407 | Belun Ring BLR-100XBelun | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K212876 | Carescape SpO2 - MasimoMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K201456 | Scan MonitorWithings | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K212160 | SimpleSENSE PlatformNanowear | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K210032 | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)Leadtek Research | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring PlatformEdwards Lifesciences | 510(k) · cleared | QAQ | Rx | FDA record · PDF |
| K210274 | Fingertip Pulse OximeterZhuhai Linte Medical Instrument | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring PlatformLifeSignals | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K211906 | Vital SignsOxehealth | 510(k) · cleared | QME | Unknown | FDA record · PDF |
| K210753 | KardiaMobile 6LAliveCor | 510(k) · cleared | DXH | Rx | FDA record · PDF |
| K202897 | Natural CyclesNatural Cycles | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K201914 | HRVWatch-Mini Wrist MonitorTaiwan Scientific | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K210086 | Vitals360 Multi-Vitals Mobile MonitorVocare | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| DEN200038 | Gili Pro BioSensor (also known as Gili BioSensor System)Continuse | De Novo · granted | QOK | Unknown | FDA record · PDF |
| DEN200019 | Oxehealth Vital SignsOxehealth | De Novo · granted | QME | Unknown | FDA record · PDF |
| K202776 | Fingertip pulse oximeterShenzhen Lepu Intelligent Medical Equipment | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K193330 | Clue Birth ControlBiowink | 510(k) · cleared | PYT | Unknown | FDA record · PDF |
| K200163 | Ava Fertility TrackerAva | 510(k) · cleared | LHD | OTC | FDA record · PDF |
| K202324 | Fingertip Pulse OximeterShenzhen BSX Technology Electronics | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| DEN200033 | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging CableNightware | De Novo · granted | QMZ | Unknown | FDA record · PDF |
| K201669 | SimpleSENSENanowear | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K201525 | ECG AppApple | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K200948 | Fitbit ECG AppFitbit | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K201168 | ECG Monitor AppSamsung | 510(k) · cleared | QDA | OTC | FDA record · PDF |
| K200690 | LifeSignals ECG Remote Monitoring Patch PlatformLifeSignals | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K193348 | Blood Pressure MonitorWellue / Viatom | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K193350 | Leadtek Fingertip Pulse OximeterLeadtek Research | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K191882 | Masimo Centroid SystemMasimo | 510(k) · cleared | MWI | Rx | FDA record · PDF |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)VitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K192875 | Philips Biosensor BX100Philips Medical Systems | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K191462 | Proov TestMFB Fertility | 510(k) · cleared | QKE | Unknown | FDA record · PDF |
| K193242 | Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20VitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K191406 | KardiaMobile, KardiaStationAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K192415 | Study Watch with Irregular Pulse MonitorVerily Life Sciences | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K191870 | VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K191059 | Masimo Rad-97 and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K191614 | BioSticker SystemBioIntelliSense | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K191088 | Checkme O2 Pulse OximeterWellue / Viatom | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K183625 | SomnaPatchRespironics | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K191417 | Belun RingBelun | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K183370 | PeraMobile and PeraWatchPerahealth | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K190792 | BB-613WPBiobeat | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K190207 | Blood Pressure MonitorWellue / Viatom | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K183282 | Biovitals Analytics EngineBiofourmis | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K182618 | SleepImage SystemSleepImage | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20VitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K183559 | WatchPAT ONEItamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K183611 | Soniquence RF Generator and Soniquence ElectrodesSoniquence | 510(k) · cleared | GEI | Unknown | FDA record · PDF |
| K183646 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - PressureEdwards Lifesciences | 510(k) · cleared | QAQ | Unknown | FDA record · PDF |
| K183697 | Masimo Rad-97 and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K183319 | Triangle SystemAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K182396 | KardiaMobile, KardiaStationAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K181658 | MobileECG 2 BTMemtec | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K183078 | VitalConnect Platform, VitalPatch BiosensorVitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K182494 | FlowMet-RLaser Associated Sciences | 510(k) · cleared | DPW | Unknown | FDA record · PDF |
| K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions | 510(k) · cleared | DXH | OTC | FDA record · PDF |
| K183556 | oCare Wrist Pulse OximeterTaiwan Biophotonic | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K181956 | Masimo MightySat Rx Fingertip Pulse OximeterMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K182456 | Study WatchVerily Life Sciences | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K180685 | AS-3XX Series Fingertip Pulse OximeterXiamen Acurio Instruments | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K180046 | Masimo Rad-97 and AccessoriesMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K181503 | Fingertip Pulse OximeterBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K173872 | FibriCheckQompium / FibriCheck | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K181006 | BB-613 Watch OximeterBiobeat | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| DEN180042 | Irregular Rhythm Notification FeatureApple | De Novo · granted | QDB | OTC | FDA record · PDF |
| DEN180044 | ECG AppApple | De Novo · granted | QDA | OTC | FDA record · PDF |
| K173976 | Masimo Acoustic Respiration Sensors, infant and neonateMasimo | 510(k) · cleared | BZQ | Unknown | FDA record · PDF |
| K172492 | Optical Topography System ETG-4100Hitachi Healthcare Americas | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K180775 | Watch-PAT300Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| DEN170052 | Natural CyclesNatural Cycles | De Novo · granted | PYT | OTC | FDA record · PDF |
| K180472 | ViSi Mobile Monitoring SystemSotera | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)HMicro | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K180174 | Belun RingBelun | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K181077 | ActiGraph CentrePoint Insight WatchActigraph | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| DEN160044 | Acumen Hypotension Prediction Index (HPI) Feature SoftwareEdwards Lifesciences | De Novo · granted | QAQ | Unknown | FDA record · PDF |
| K172366 | Wrist Pulse OximeterBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K172799 | Positional Sleep Assessment System (PoSAS) softwareAdvanced Brain Monitoring | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K171121 | Masimo Root Monitoring System and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K171816 | Kardia Band SystemAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K170965 | Fingertip Pulse OximeterShenzhen Jumper Medical Equipment | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K163453 | VitalPatch® VitalConnect PlatformVitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K163696 | SleepImage SystemSleepImage | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K170168 | Masimo Rad-97 and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K170973 | VitalWatch Software User InterfaceVitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K161938 | Fingertip Pulse OximeterXuzhou Yongkang Electronic Science Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K161579 | Watch-PAT200UItamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K161916 | TelePatch Cardiac MonitorMedicomp | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K161431 | SimplECGNanowear | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K160940 | Masimo Disposable Transflectance Forehead SensorMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K153021 | Fingertip Pulse Oximeter A310Amemo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K161560 | Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K152091 | Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K152089 | Wrist Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K160685 | Surveyor S4 Mobile MonitorMortara Instrument | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K153070 | Watch-PAT200UItamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K153473 | Braemar Telemetry Patch SystemBraemar Manufacturing | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K153225 | Masimo Root Monitoring System and AccessoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K151784 | ActTrustCondor Instruments | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K152258 | T3 SoftwareEtiometry | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K153160 | AVIVO Mobile Patient Management (MPM) SystemMedtronic | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K153335 | AlertWatch: ORAlertwatch | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K151644 | Masimo Root Vital Signs Monitoring System and AccessoriesMasimo | 510(k) · cleared | MWI | Rx | FDA record · PDF |
| K151835 | Vital Signs Patch SystemLifewatch Technologies | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DGuangdong Biolight Meditech | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K152341 | ViSi Mobile Monitoring SystemSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K150869 | Checkme Pro Health MonitorWellue / Viatom | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatchVitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K150314 | Masimo MightySat Rx Fingertip Pulse OximeterMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K151206 | Fingertip Pulse OximeterBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K151330 | Microlife Wrist Watch Blood Pressure MonitorMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K142512 | Personalized Physiology Analytics Engine softwareVGBio (dba physIQ) | 510(k) · cleared | PLB | Unknown | FDA record · PDF |
| K150361 | ViSi Mobile Monitoring SystemSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K143032 | eMotion Faros ECG MobileMega Electronics | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K142888 | Fingertip Pulse OximeterBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K142743 | AliveCor Heart MonitorAliveCor | 510(k) · cleared | DXH | Rx | FDA record · PDF |
| K143751 | Visi Mobile Monitoring SystemSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K132407 | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)Lifewatch Technologies | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K141020 | SURVEYOR S4 MOBILE MONITORMortara Instrument | 510(k) · cleared | DRG | Rx | FDA record · PDF |
| K142672 | AliveCor Heart MonitorAliveCor | 510(k) · cleared | DXH | Rx | FDA record · PDF |
| K142394 | Masimo Root Monitoring System and AccesoriesMasimo | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K140582 | FINGERTIP PULSE OXIMETERShenzhen Jumper Medical Equipment | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K141083 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITORMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K140933 | ALIVECOR HEART MONITORAliveCor | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K141128 | FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K141167 | VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)VitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K140682 | FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K140188 | MASIMO ROOT MONITORING SYSTEMMasimo | 510(k) · cleared | MWI | Rx | FDA record · PDF |
| K133859 | WATCH-PAT200U (WP200U)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K132447 | VITALCONNECT PLATFORM BY VITAL CONNECT INC.VitalConnect | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K133125 | WITHINGS BLOOD PRESURE MONITORWithings | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K133090 | OXICARE FINGERTIP PULSE OXIMETERDelbio | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K130401 | ALERTWATCH: ORAlertwatch | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K130921 | ALIVECOR HEART MONITOR OTCAliveCor | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K132764 | MOTION WATCH AND PRO-DIARYCamntech | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K131000 | V-PATCH SYSTEMIntelesens | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K133586 | VISI MOBILE MONITIORING SYSTEMSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K132803 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINKMedApps (dba Alere Connect) | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K132148 | S HEALTHSamsung | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K131699 | EMOTION ECG MOBILEMega Electronics | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K131047 | FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | OTC | FDA record · PDF |
| K130709 | VISI MOBILE MONITORING SYSTEMSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K130947 | FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K123130 | ANSWATCH WRIST MONITOR MODEL TS-0411Taiwan Scientific | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K131111 | IHEALTH FINGERTIP PULSE OXIMETERAndon Health | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K130409 | ALIVECOR HEART MONITORAliveCor | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K123871 | FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSORMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K122046 | WRIST PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K122927 | OXICARE FINGERTIP PULSE OXIMETERDelbio | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K120502 | PC-60NW FINGERTIP OXIMETERShenzhen Creative Industry | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K122333 | MOBILECARE MONITORAframe Digital | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K122356 | ALIVECOR HEART MONITOR FOR IPHONEAliveCor | 510(k) · cleared | DPS | Unknown | FDA record · PDF |
| K121697 | FINGERTIP PULSE OXIMETERAndon Health | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLEMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K122036 | VISI MOBILE MONITORING SYSTEMSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K120430 | MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3PMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K121912 | E1 EAR SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K120325 | CONNECTED CARE MOBILE APPLICATIONWatermark Medical | 510(k) · cleared | DRG | Unknown | FDA record · PDF |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEMMedicalgorithmics | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LTWelch Allyn | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K112478 | VISI MOBILE MONITORING SYSTEMSotera | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K113596 | MASIMO SET REUSABLE OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K112804 | FINGERTIP PULSE OXIMETERGuangdong Biolight Meditech | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K113187 | AVIVO MOBILE PATIENT MANAGEMENTCorventis | 510(k) · cleared | MHX | Unknown | FDA record · PDF |
| K111403 | MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K112822 | SLEEPSTRIP IIS.L.P. | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K112102 | MICHELE SLEEP SCORING SYSTEMSYounes Sleep Technologies | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2Sleep Performance (dba Fatigue Science) | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K111621 | MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K111888 | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K102567 | WATCH-PAT 200S-3 (WP200S-3)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K110872 | WITHINGS BLOOD PRESSURE MONITORWithings | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K110028 | MASIMO RADICAL Y PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101577 | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIESBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101031 | MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1Masimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101871 | TRUSIGNAL SPO2 FINGERTIP SENSORGE Healthcare Finland | 510(k) · cleared | DQA | Unknown | FDA record |
| K100763 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K100428 | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101512 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K100403 | MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7Masimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K100815 | OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316Oxypulse | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K100617 | MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20DMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K101275 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K094046 | LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K093757 | MD300C1 FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K092652 | FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CABeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K092620 | MD300C318 FINGERTIP PULSE OXIMETERBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K091241 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K092456 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3CMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K092838 | MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8Masimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K092003 | CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARESleepImage | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K091971 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEMCorventis | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K090662 | MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIPMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K090165 | RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20Masimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K091057 | MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K083622 | LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K083287 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEMCorventis | 510(k) · cleared | DSI | Unknown | FDA record · PDF |
| K082881 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLContec Medical System | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K082357 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K082052 | MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECKMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K081485 | SOMNOWATCHSomnomedics | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K081712 | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700Guangdong Biolight Meditech | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K081659 | RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-LMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K081982 | WATCH-PAT 200S-2 (WP200S-2)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K081125 | WRIST PULSE OXIMETER MD300WBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K081037 | WATCH-PAT 200I (WP200I)Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K080427 | WATCH-PAT MODEL 100S-2Itamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K080238 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K073454 | FINGERTIP PULSE OXIMETER, MODEL CMS-50CContec Medical System | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K073269 | HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEMHypnocore | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K070855 | SLEEP QUALITYDynadx | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K073024 | MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K072825 | FINGERTIP PULSE OXIMETER, MODEL MD300IBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K073198 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP HOME (BP3MX1-1)Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K073094 | VITALLINK3 MOBILE VITAL SIGNS SYSTEMTelemedic Systems | 510(k) · cleared | MWI | Unknown | FDA record · PDF |
| K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)Microlife | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K070371 | FINGERTIP PULSE OXIMETER MD300CBeijing Choice Electronic Technology | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K071024 | MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K070326 | NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEMWidemed | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K063140 | RAINBOW ADHESIVE CO-OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K061204 | MASIMO SET RADICAL 7 PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K061558 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4UMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K060143 | LNCS AND SPO2.COM SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K061403 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4UMicrolife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K053477 | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K053269 | MASIMO SET RAD-8 PULSE OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K052829 | WRISTOX MODEL 3100 PULSE OXIMETERNonin Medical | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K051439 | LNOP BLUE OXIMETRY SENSORMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K051212 | MODIFICATION TO LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K050252 | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K050670 | SENSOR MOBILE SM 100 VITAPHONE 1001R REMOSTMS Telemedizinische Systeme | 510(k) · cleared | DXH | Unknown | FDA record · PDF |
| K050068 | LNOPV AD-L AND PD-L OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K042536 | MASIMO SET RAD 57 PULSE CO-OXIMETERMasimo | 510(k) · cleared | DQA | Rx | FDA record · PDF |
| K042916 | WATCH PAT 100SItamar | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K042501 | ETG-4000 OPTICAL TOPOGRAPHY SYSTEMHitachi Medical | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K042253 | SLEEPSENSE SLEEP SENSORSS.L.P. | 510(k) · cleared | MNR | Rx | FDA record · PDF |
| K042346 | LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K040178 | PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICES.P.O. Medical Equipment | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K041815 | LNCS OXIMETRY SENSORSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K040932 | EASYNET BODY POSITION MODULECadwell Laboratories | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K040986 | CADWELL LIMB MOVEMENT MODULECadwell Laboratories | 510(k) · cleared | LEL | Unknown | FDA record · PDF |
| K033402 | PORTABLE SLEEP DATA RECORDER (PSDR)Pro-Tech Services | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K041204 | NC SP02 ADAPTER CABLEMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K040259 | MASIMO SET INTELLIVUE PULSE OXIMETER MODULEMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K040002 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1Microlife Intellectual Property | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K033998 | MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5VMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K040214 | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K032551 | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSORMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K033296 | MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5VMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K033349 | AC-1 SP02 ADAPTOR CABLE, MODEL AC-1Masimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K033298 | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELSMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K030668 | MODEL 3100 WRISTOX PULSE OXIMETERNonin Medical | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K022506 | MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEMWidemed | 510(k) · cleared | MNR | Rx | FDA record · PDF |
| K031330 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K021138 | SLEEPSCREEN/APNOESCREEN CARDIOErich Jaeger | 510(k) · cleared | MNR | Rx | FDA record · PDF |
| K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'Dolphin Medical | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K020607 | SLEEPFLO, MODEL 101501Biomec | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K012437 | DEVILBISS SLEEP RECORDER MODEL # RM60Sunrise Medical Hhg | 510(k) · cleared | MNR | Unknown | FDA record · PDF |
| K021305 | MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTERMicrolife | 510(k) · cleared | DXN | Unknown | FDA record · PDF |
| K010156 | SLEEP PAT 200 DEVICEItamar | 510(k) · cleared | MNR | Unknown | FDA record |
| K013792 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K010739 | WATCH-PAT 100Itamar | 510(k) · cleared | MNR | Unknown | FDA record |
| K012626 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOROSI Medical | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K012992 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K010732 | VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)Telemedic Systems | 510(k) · cleared | MWI | Unknown | FDA record |
| K011320 | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEMHitachi Medical Systems America | 510(k) · cleared | DQA | Unknown | FDA record |
| K011851 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record · PDF |
| K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETERBCI | 510(k) · cleared | DQA | Unknown | FDA record |
| K011523 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K002036 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MODOSI Medical | 510(k) · cleared | DQA | Unknown | FDA record |
| K010498 | WRISTWATCH BLOOD PRESSURE MONITOR A46Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K002665 | WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120K-Jump Health | 510(k) · cleared | DXN | Unknown | FDA record |
| K010419 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320Respironics | 510(k) · cleared | LEL | Unknown | FDA record |
| K010190 | WRISTWATCH BLOOD PRESSURE MONITOR, MODEL A43Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K002135 | SLEEPSTRIP DISPOSABLE APNEA SCREENERInfluent | 510(k) · cleared | MNR | Unknown | FDA record |
| K003167 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K003244 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K002939 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETERMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K002751 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K002682 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K002477 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K002574 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDTMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K001182 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1Microlife | 510(k) · cleared | DXN | Unknown | FDA record |
| K000126 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIAMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K993460 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K993426 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K993429 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K993542 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K993432 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K993555 | MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K992238 | MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)Masimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K992340 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K990966 | MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DISMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K981969 | ULTIMA BODY POSITION SENSORBraebon Medical | 510(k) · cleared | LEL | Unknown | FDA record |
| K964153 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000Rossmax International | 510(k) · cleared | DXN | Unknown | FDA record |
| K980824 | A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITORA&D Engineering | 510(k) · cleared | DXN | Unknown | FDA record |
| K973887 | MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K971501 | SLEEPSCAN AIRFLOW PRESSURE TRANSDUCERBio-Logic Systems | 510(k) · cleared | MNR | Unknown | FDA record |
| K961817 | B SMART MODEL 1Koven Technology | 510(k) · cleared | LEL | Unknown | FDA record |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITORNeurim Pharmaceuticals | 510(k) · cleared | LEL | Unknown | FDA record |
| K955841 | SLEEP SYSTEM FOR CLINICS & RESEARCHCompumedics | 510(k) · cleared | MNR | Unknown | FDA record |
| K962603 | MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLESMasimo | 510(k) · cleared | DQA | Unknown | FDA record |
| K964494 | SLEEPWIZARDNellcor Puritan Bennett | 510(k) · cleared | MNR | Unknown | FDA record |
| K962103 | BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETERBio-Logic Systems | 510(k) · cleared | MNR | Unknown | FDA record |
| K945476 | HEARTHWATCH III(TM)Instromedix | 510(k) · cleared | DXH | Unknown | FDA record |
| K950273 | SLEEP TEST(TM)CNS | 510(k) · cleared | MNR | Unknown | FDA record |
| K944395 | ELCAT D-PPG, PLETHYSMOGRAPH DEVICEDermatology Assoc | 510(k) · cleared | JOM | Unknown | FDA record |
| K912817 | SOMNIMIC (R)Somnitec | 510(k) · cleared | LEL | Unknown | FDA record |
| K896500 | CWD/PPG MODULELife Sciences Manufacturing | 510(k) · cleared | JOM | Unknown | FDA record |
| K884451 | DOPCORD PPGHuntleigh Technology | 510(k) · cleared | JOM | Unknown | FDA record |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICSZygo Industries | 510(k) · cleared | LEL | Unknown | FDA record |
| K843905 | TRAUMA CARE EVALUATIONQuantitative | 510(k) · cleared | PLB | Unknown | FDA record |
| K831676 | BIOSENSOR ASC SYSTEMBiosensor | 510(k) · cleared | DSI | Unknown | FDA record |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPHSonicaid | 510(k) · cleared | JOM | Unknown | FDA record |
| K792305 | A SLEEP ASSESSMENT DEVICEFarrall Instruments | 510(k) · cleared | LEL | Unknown | FDA record |
Download all 459 records as CSV. Claim and sensor columns are our labels, not FDA fields.
What the product codes mean
FDA files every device under a three-letter product code tied to a classification regulation in 21 CFR. The code tells you what kind of device FDA considers it, which matters more than the marketing name. Names, classes and regulations below come from openFDA's classification data; the definition column quotes FDA's own definition where FDA publishes one.
| Code | FDA name | Class · 21 CFR | Records |
|---|---|---|---|
| DQA | Oximeter | Class 2 · 870.2700 | 151 |
| MNR | Ventilatory Effort Recorder | Class 2 · 868.2375 | 50 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class 2 · 870.1130 | 42 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class 2 · 870.2300 | 31 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 · 870.2910 | 24 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | Class 2 · 870.2920 | 24 |
| LEL | Device, Sleep Assessment | Class 2 · 882.5050 | 19 |
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | Class 2 · 870.2785 | 13 |
| DPS | Electrocardiograph | Class 2 · 870.2340 | 12 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 · 870.1025 | 12 |
| DSI | Detector And Alarm, Arrhythmia | Class 2 · 870.1025 | 10 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | Class 2 · 870.2345 | 9 |
| PLB | Multivariate Vital Signs Index | Class 2 · 870.2300 | 8 |
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | Class 2 · 884.5370 | 7 |
| QAQ | Adjunctive Predictive Cardiovascular Indicator | Class 2 · 870.2210 | 5 |
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | Class 2 · 870.2790 | 5 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Class 2 · 870.2780 | 4 |
| QRS | Device For Sleep Apnea Testing Based On Mandibular Movement | Class 2 · 868.2376 | 3 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | Class 2 · 868.2378 | 3 |
| BZQ | Monitor, Breathing Frequency | Class 2 · 868.2375 | 2 |
| OLK | Pulse Oximeter For Over-The-Counter Use | Class 2 · 870.2700 | 2 |
| QOK | Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate | Class 2 · 870.2786 | 2 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | Class 2 · 870.2380 | 2 |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | Class 2 · 870.2705 | 2 |
| QZA | Body Temperature Sensing Software | Class 2 · 880.2915 | 2 |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | Class 2 · 870.2380 | 2 |
| DQK | Computer, Diagnostic, Programmable | Class 2 · 870.1425 | 1 |
| LHD | Device, Fertility Diagnostic, Proceptive | Class U | 1 |
| QMZ | Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | Class 2 · 882.5705 | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | Class 2 · 868.2250 | 1 |
| QWE | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry | Class 2 · 870.2720 | 1 |
| QXY | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature | Class 2 · 870.1135 | 1 |
| SDY | Loss Of Pulse Notification Software | Class 2 · 870.2790 | 1 |
| SFR | Hypertension Machine Learning-Based Notification Software | Class 2 · 870.2380 | 1 |
How this database is built
Official fields. FDA number, pathway, applicant, device name, product code, regulation, class, received and decision dates, decision and 510(k) type are copied from openFDA's device 510(k) endpoint, which carries both K numbers and De Novo (DEN) numbers. Before launch we compared all 458 openFDA records against the live openFDA API (number, decision date, received date, applicant, product code, device name and decision code) and found no mismatches. We also opened 17 records (16 picked at random, plus DEN230041) on FDA's own 510(k) and De Novo pages and confirmed the number, applicant, product code and decision date on each.
Parsed from FDA documents. Indications for use, predicate numbers and most Rx/OTC labels were extracted automatically from FDA summary PDFs, some through OCR. They are shown as parsed text with a link to the PDF, never as verified quotes. Predicate parsing picks up FDA numbers near the word "predicate", so a list can include reference devices. Rx or OTC is known for 56 of 459 records; the rest say "unknown" because no document we parsed states it.
Our labels. The claim (for example SpO2, blood pressure or AFib) and sensor (wrist PPG, finger PPG, ring PPG, camera, ECG, cuff) columns are heuristics assigned from the product code, device name and applicant. They help you filter; FDA does not publish them.
Scope. Records were selected by product code (oximeters, photoplethysmograph software, ECG and arrhythmia software, blood pressure, sleep apnea, sleep assessment, patient monitors and related codes) plus applicant searches for wearable brands. It is not a copy of FDA's whole 510(k) database. For anything outside this scope, use FDA's 510(k) search (see our 510(k) lookup guide).
Freshness. openFDA lags FDA's website by days to weeks. The data here runs through Oct 26, 2026, and the list is refreshed from a weekly sync.
Guides
Questions
- What is in this FDA database?
- 459 FDA records for PPG, pulse oximetry, wearable ECG, arrhythmia, blood pressure, sleep and remote-monitoring devices: 443 510(k) clearances and 16 De Novo grants from 166 companies. The numbers, dates, applicants and product codes come from openFDA, which carries data through Oct 26, 2026.
- Why are there no PMA approvals?
- openFDA's PMA endpoint returned no records under the product codes this database covers. These device types reach the US market through 510(k) clearance or De Novo classification. The PMA filter stays so that a PMA record can be added if one appears.
- How accurate are the indications, predicates and Rx/OTC labels?
- Those fields were parsed automatically from FDA summary PDFs, some of them with OCR, so they can contain extraction errors. Each record page labels them as parsed and links the FDA source. Rx or OTC status is filled for 56 records where a document states it, and shows "unknown" everywhere else.
- Is a device in this list FDA approved?
- Usually not in FDA's sense of the word. A 510(k) device is "cleared", a De Novo device is "granted" (authorized), and only a PMA device is "approved". The cleared vs approved guide explains the difference.