# K201525: ECG App

- Pathway: 510(k) (Traditional)
- Applicant: Apple, Inc.
- Decided: Oct 8, 2020 after 122 days
- Product code: QDA (Electrocardiograph Software For Over-The-Counter Use)
- Device class: 2
- Regulation: 21 CFR 870.2345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180044 (2018). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180044: ECG App, Apple, Inc. (2018) Summary page 4.

## Most influential descendants
- K240795: Withings ECG App (2025), 0 descendants of its own
- K243236: WHOOP ECG (electrocardiogram) Feature (1.0) (2025), 0 descendants of its own
- K240909: Samsung ECG App v 1.3 (ECG) (2024), 0 descendants of its own

## Indications for use
The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (no detected AF with heart rate 100-150 bpm) on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for use by people under 22 years old.

Source page: https://510kreport.com/device/K201525
Methodology: https://510kreport.com/methodology