# K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: May 2, 2023 after 89 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: 2 generations back to DEN180044 (2018). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- DEN180042: Irregular Rhythm Notification Feature, Apple, Inc. (2018) Summary page 4.
- K201168: ECG Monitor App, Samsung Electronics Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K240909: Samsung ECG App v 1.3 (ECG) (2024), 0 descendants of its own

## Indications for use
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. Following this prompt, or based on the user’s own initiative, the app is intended to create, record, store, transfer, and display a single-channel ECG, similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification. The app is not intended for users with other known arrhythmias, and it is not intended to replace traditional methods of diagnosis or treatment. 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/K230292
Methodology: https://510kreport.com/methodology