# K122356: Alivecor Heart Monitor for Iphone

- Pathway: 510(k) (Traditional)
- Applicant: AliveCor, Inc.
- Decided: Nov 19, 2012 after 108 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The AliveCor Heart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Source page: https://510kreport.com/device/K122356
Methodology: https://510kreport.com/methodology