Fitbit, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fitbit, Inc.” (first 2014, latest 2025), plus 1 De Novo decision, across 5 product codes in 3 review panels. Median 510(k) review time under this name: 156 days. Since 2017 the median was 154 days, against 152 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 164 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 156 |
| 2021 | 0 | — |
| 2022 | 1 | 252 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 109 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fitbit, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QZA | Body Temperature Sensing Software | 2 | 1 |
| MNW | Analyzer, Body Composition | 1 | 1 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 1 | 1 |
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 1 | 1 |
| SDY | Loss Of Pulse Notification Software | 1 | 1 |
Review panels
Most recent Fitbit, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242967 | Loss of Pulse Detection | SDY | 2025-02-25 | 152 |
| K243778 | Body Temperature Software (BTS) | QZA | 2025-02-13 | 66 |
| K212372 | Fitbit Irregular Rhythm Notifications | QDB | 2022-04-08 | 252 |
| K200948 | Fitbit ECG App | QDA | 2020-09-11 | 156 |
| K133872 | ARIA WIFI SMART SCALE | MNW | 2014-06-02 | 164 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230050 | De Novo | Body Temperature Sensing Software | 2023-12-15 |
Recalls
openFDA lists no recalls under a recalling firm named Fitbit, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Fitbit, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04380415: Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch (Completed, started 2020-05-06)
- NCT04176926: Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch (Completed, started 2019-10-29)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fitbit, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Fitbit, Inc.” (first 2014, latest 2025), plus 1 De Novo decision, across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fitbit, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fitbit, Inc. is 156 days. Since 2017: 154 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Fitbit, Inc.?
The most frequent FDA product codes under this applicant name are QZA (Body Temperature Sensing Software, 2); MNW (Analyzer, Body Composition, 1); QDA (Electrocardiograph Software For Over-The-Counter Use, 1).
Next steps
- See all 5 Fitbit, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QZA, Fitbit, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.