510(k) · Cleared
ClearedGarmin ECG App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Garmin International, Inc. · QDA Electrocardiograph Software For Over-The-Counter Use
Cleared on Jan 12, 2023 as substantially equivalent to DEN180044 (Apple, Inc., 2018) after a 205-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jan 12, 2023
- Review
- 205 days
- Class
- Class II
- Product code
- QDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180044 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180044 ECG AppApple, Inc. · 2018
- This deviceK221774 Garmin ECG AppGarmin International, Inc. · 2023
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) | K221774 | Garmin ECG App | Garmin International, Inc. | 2023 | — |
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…Regulatory Class Class II Predicate Device: Predicate Manufacturer Apple Inc. Predicate Trade Name Apple ECG App Predicate 510(k) DEN180044 3 Device Description The Garmin ECG App (ECG App) is a software-only, mobile medical application that has two components: (1)… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN180044.
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 Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm (SR) 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…
Read the full statement (154 words)
The Garmin ECG app is a software-only, mobile medical application intended for use with compatible Garmin smartwatches to create, record, store, transfer, and display a single-channel electrocardiograph similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm (SR) 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 SR, and it is 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/K221774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221774: Garmin ECG App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221774
Report an extraction error
Are you the manufacturer?
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