FDA 510(k) · Masimo
K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (Masimo Corporation)
Masimo Corporation received FDA 510(k) K181956 for Masimo MightySat Rx Fingertip Pulse Oximeter, with a decision date of Jan 23, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K181956 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo MightySat Rx Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 23, 2018 |
| Decision date | Jan 23, 2019 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
statement for the MightySat Rx is similar to the primary predicate (K141518). Both the subject and predicate device have the same intended use for vital sign monitoring, by transmitting and detecting light through tissue in the finger. Device Specifications The MightySat Rx specifications are as follows: FEATURE SPECIFICATION Display Display Type OLED color display Oxygen Saturation (SpO2): 0-100% Pulse Rate (PR): 25-240 beats per minute (BPM) Perfusion Index (Pi): 0.02-20% Display Range Pleth Variability Index (PVi): 0-100% Respiration rate (RRp): : 4-70 respirations per minute (RPM) Photoplethysmogram Display Waveform Signal IQ SpO2: 1% Display Resolution PR: 1 BPM RRp: 1 RPM Measurement Accuracy in Accordance with ISO 80601-2-61 SpO2, No Motion 70 - 100%, 2%, ARMS, adults/pediatrics SpO2, Motion 70 - 100%, 3% ARMS, adults/pediatrics SpO2, Low Perfusion 70 - 100%, 2%, ARMS, adults/pediatrics Pulse Rate, No Motion 25 - 240 BPM, 3 BPM ARMS, adults/pediatrics Pulse Rate, Motion 25 - 240 BPM, 5 BPM ARMS, adults/pediatrics Pulse Rate, Low Perfusion 25 - 240 BPM, 3 BPM ARMS, adults/pediatrics RRp 4 - 70 RPM, 3 RPM ARMS, 1 RPM Mean Error, adults Power K181956
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K181956
- K214115 MightySat -OTC (Masimo, Jan 31, 2024, OLK)
- K220351 Polso Watch (Chronisense Medical, Nov 18, 2022, DQA)
- K212153 Biobeat Platform, BB-613WP Patch (Biobeat, Mar 25, 2022, DQA)
- K201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (Masimo, Sep 24, 2020, DQA)
- K193242 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories (Masimo, Feb 27, 2020, MWI)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.