FDA 510(k) · Samsung
K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (Samsung Electronics Co., Ltd.)
Samsung Electronics Co., Ltd. received FDA 510(k) K230292 for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification, with a decision date of May 2, 2023 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K230292 |
|---|---|
| Pathway | 510(k) |
| Applicant | Samsung Electronics Co., Ltd. |
| Device name | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification |
| Product code | QDA: Electrocardiograph Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2345 |
| Device class | Class 2 |
| Date received | Feb 2, 2023 |
| Decision date | May 2, 2023 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K230292
- K240909 Samsung ECG App v 1.3 (ECG) (Samsung, Aug 2, 2024, QDA)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's definition: "An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis."
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.