# K140933: Alivecor Heart Monitor

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Aug 15, 2014 after 126 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 11 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130921: Alivecor Heart Monitor Otc, AliveCor, Inc. (2014) Summary page 4.
- K052767: Afibalert Atrial Fibrillation Detector, Lechnologies Research, Inc. (2006) Summary page 4.
- K122184: Ecg Check, Cardiac Designs, LLC (2013) Summary page 4.

## Most influential descendants
- K142743: AliveCor Heart Monitor (2015), 19 descendants of its own
- K171816: Kardia Band System (2017), 12 descendants of its own
- K201456: Scan Monitor (2021), 6 descendants of its own
- K181823: KardiaAI (2019), 6 descendants of its own
- K142672: AliveCor Heart Monitor (2014), 4 descendants of its own

## Recalls of this device
- Jan 9, 2015 · Class III · Z-1125-2015: Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.

## 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 (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.

Source page: https://510kreport.com/device/K140933
Methodology: https://510kreport.com/methodology