FDA 510(k) · AliveCor
K210753: KardiaMobile 6L (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K210753 for KardiaMobile 6L, with a decision date of Jun 30, 2021 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K210753 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | KardiaMobile 6L |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Mar 15, 2021 |
| Decision date | Jun 30, 2021 |
| 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
[807.92(a)(5)] KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. KardiaMobile 6L is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use. Substantial Equivalence The KardiaMobile 6L subject device has the same intended use, physical characteristics, technological characteristics and software as the K183319, Triangle System (marketed as “KardiaMobile 6L”) predicate device. The difference between the two devices is labeling only, in that the subject device expands the use by HCPs to measure the QT interval in addition to the rhythm analysis application in the predicate. This expanded use has been analyzed and addressed through performance testing. The testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness. QT interval measurement is prescription use. K210753
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.
- K183319 Triangle System (AliveCor)
Later records that cite K210753
- K220350 KardiaMobile 6L (AliveCor, May 25, 2022, DXH)
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 DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.