De Novo · Granted
GrantedECG App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · QDA Electrocardiograph Software For Over-The-Counter Use
Granted on Sep 11, 2018 as a new device type through De Novo after a 28-day review. 12 later devices descend from it.
- Decided
- Sep 11, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- QDA
- Recalls
- None
12 later devices descend from it, 5 citing it directly.
- This deviceDEN180044 ECG AppApple, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK201525 ECG AppApple, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK201168 ECG Monitor AppSamsung Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK191406 KardiaMobile, KardiaStationAliveCor, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK230292 Samsung ECG Monitor Application with Irregular Heart Rhythm…Samsung Electronics Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK240795 Withings ECG AppWithings · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K201525ECG AppApple, Inc. · 2020 · cites it directly3descendants
- K201168ECG Monitor AppSamsung Electronics Co., Ltd. · 2020 · cites it directly3descendants
- K191406KardiaMobile, KardiaStationAliveCor, Inc. · 2020 · cites it directly2descendants
- K230292Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. · 2023 · 2 generations on1descendant
- K240795Withings ECG AppWithings · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180044 | ECG App | Apple, Inc. | 2018 | — |
| +1 | K201525 | ECG App | Apple, Inc. | 2020 | — |
| +1 | K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020 | — |
| +1 | K191406 | KardiaMobile, KardiaStation | AliveCor, Inc. | 2020 | — |
| +2 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023 | — |
| +2 | K240795 | Withings ECG App | Withings | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (12)
See all 125 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?
- Of its descendants, K201525 (Apple, Inc., 2020) has gone furthest, with 3 descendants of its own.
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. 2018, 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 ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias. The ECG app is intended for over-the-counter (OTC) use. The ECG…
Read the full statement (153 words)
The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.
The ECG app is not intended for use by people under 22 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180044 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180044: ECG App.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180044
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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