# K220350: KardiaMobile 6L

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: May 25, 2022 after 107 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K963725 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210753: KardiaMobile 6L, AliveCor, Inc. (2021) Summary page 4.

## Indications for use
KardiaMobile 6L is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) thythms. 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-1II and unipolar limb leads aVR, aVF and aVL. KardiaMobile 6L also displays ECG rhythms and output of ECG analysis from AliveCor’s KardiaAl 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.

Source page: https://510kreport.com/device/K220350
Methodology: https://510kreport.com/methodology