# K142743: AliveCor Heart Monitor

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Jan 27, 2015 after 125 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: 5 generations back to K963725 (1997). 12 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140933: Alivecor Heart Monitor, AliveCor, Inc. (2014) Summary page 4.

## Most influential descendants
- K171816: Kardia Band System (2017), 12 descendants of its own
- K181823: KardiaAI (2019), 6 descendants of its own
- K183319: Triangle System (2019), 3 descendants of its own
- K182456: Study Watch (2019), 3 descendants of its own
- K210753: KardiaMobile 6L (2021), 2 descendants of its own

## Indications for use
The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The AliveCor Heart Monitor 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 it is not intended for pediatric use.

Source page: https://510kreport.com/device/K142743
Methodology: https://510kreport.com/methodology