510(k) · Cleared
ClearedSamsung ECG Monitor Application with Irregular Heart Rhythm Notification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · QDA Electrocardiograph Software For Over-The-Counter Use
Cleared on May 2, 2023 as substantially equivalent to DEN180042 (Apple, Inc., 2018) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- May 2, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- QDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN180044 (2018). 3 ancestors in all, the oldest DEN180042 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN180044 ECG AppApple, Inc. · 2018
- 1 generation backK201168 ECG Monitor AppSamsung Electronics Co., Ltd. · 2020
- This deviceK230292 Samsung ECG Monitor Application with Irregular Heart Rhythm…Samsung Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240909 Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180044 | ECG App | Apple, Inc. | 2018 | — |
| −1 | K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020 | — |
| 0 (this device) | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023 | — |
| +1 | K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDA device
- #1 K240795 Withings ECG Appscore 9.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180042 | Irregular Rhythm Notification FeatureSummary page 4…nalysis Software For Over-The-Counter Use (21 CFR 870.2790) Predicate Device: • Primary: Apple Irregular Rhythm Notification Feature (DEN180042) • Secondary: Samsung ECG Monitor App (K201168) Device Description The Samsung ECG Monitor App with I… | 2018 |
| * | K201168 | ECG Monitor AppSummary page 4…FR 870.2790) Predicate Device: • Primary: Apple Irregular Rhythm Notification Feature (DEN180042) • Secondary: Samsung ECG Monitor App (K201168) Device Description The Samsung ECG Monitor App with Irregular Heart Rhythm Notification (IHRN) Feature is a software as a medi… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240909 | Samsung ECG App v 1.3 (ECG) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240909 (Samsung Electronics Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate DEN180042.
How does its category compare?
All QDA devicesQDA Electrocardiograph Software For Over-The-Counter Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QDA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QDA
122in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDA
No recall names QDA since 2007.
Adverse event reports per year · QDA
5in 2025
MAUDE reports naming product code QDA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | 122 | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (230 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230292: Samsung ECG Monitor Application with Irregular Heart Rhythm Notification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230292
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026