# K130921: Alivecor Heart Monitor Otc

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Feb 6, 2014 after 309 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140933: Alivecor Heart Monitor (2014), 28 descendants of its own
- 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

## Indications for use
The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.

Source page: https://510kreport.com/device/K130921
Methodology: https://510kreport.com/methodology