# K201168: ECG Monitor App

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Aug 4, 2020 after 95 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; 2 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
- K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (2023), 1 descendant of its own
- K243305: Masimo W1 (2025), 0 descendants of its own
- K240909: Samsung ECG App v 1.3 (ECG) (2024), 0 descendants of its own

## Indications for use
The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Source page: https://510kreport.com/device/K201168
Methodology: https://510kreport.com/methodology