# DEN180044: ECG App

- Pathway: De Novo (Direct)
- Applicant: Apple, Inc.
- Decided: Sep 11, 2018 after 28 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
No predicates in its family tree.
12 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K201525: ECG App (2020), 3 descendants of its own
- K201168: ECG Monitor App (2020), 3 descendants of its own
- K191406: KardiaMobile, KardiaStation (2020), 2 descendants of its own
- K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (2023), 1 descendant of its own
- K240795: Withings ECG App (2025), 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) or sinus rhythm 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 normal sinus rhythm and 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/DEN180044
Methodology: https://510kreport.com/methodology