510(k) · Cleared
ClearedECG Monitor App
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 Aug 4, 2020 as substantially equivalent to DEN180044 (Apple, Inc., 2018) after a 95-day review. Its family tree reaches back 1 generation to 2018. 3 later devices descend from it.
- Decided
- Aug 4, 2020
- Review
- 95 days
- Class
- Class II
- Product code
- QDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180044 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180044 ECG AppApple, Inc. · 2018
- This deviceK201168 ECG Monitor AppSamsung Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK230292 Samsung ECG Monitor Application with Irregular Heart Rhythm…Samsung Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243305 Masimo W1Masimo Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK240909 Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. · 2023 · cites it directly1descendant
- K243305Masimo W1Masimo Corporation · 2025 · cites it directly0descendants
- K240909Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180044 | ECG App | Apple, Inc. | 2018 | — |
| 0 (this device) | K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020 | — |
| +1 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023 | — |
| +1 | K243305 | Masimo W1 | Masimo Corporation | 2025 | — |
| +2 | K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | DEN180044 | ECG AppSummary page 4…pp Classification: QDA - Electrocardiograph software for over-the-counter use (21 CFR 870.2345) Predicate Device: Apple ECG App (DEN180044) Device Description The Samsung ECG Monitor Application consists of a pair of mobile medical apps: one on a compatible Samsung… | 2018 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2020, 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 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…
Read the full statement (121 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201168: ECG Monitor App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201168
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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