510(k) · Cleared
ClearedFitbit ECG App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fitbit, Inc. · QDA Electrocardiograph Software For Over-The-Counter Use
Cleared on Sep 11, 2020 as substantially equivalent to DEN180044 (Apple, Inc., 2018) after a 156-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Sep 11, 2020
- Review
- 156 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 deviceK200948 Fitbit ECG AppFitbit, Inc. · 2020
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) | K200948 | Fitbit ECG App | Fitbit, Inc. | 2020 | — |
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…Number K200948 Predicate Device Information: Name of Device: ECG App Manufacturer: Apple, Inc. De Novo Petition Number: DEN180044 Indications for Use The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearabl… | 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. 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 Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias. The Fitbit…
Read the full statement (161 words)
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit 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 Fitbit 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/K200948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200948: Fitbit 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/K200948
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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