# Fitbit, Inc.

- Location (FDA's records): San Francisco, CA
- FDA decisions: 6 (2014–2025): 5 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Fitbit, Inc. (3); Fitbit, LLC (2); Fitbit (1)
- Product codes: QZA (2), SDY (1), QDB (1), MNW (1), QDA (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apple, Inc.: 2 (https://510kreport.com/company/apple)
- Zhongshan Transtek Electronics Co., Ltd.: 1 (https://510kreport.com/company/zhongshan-transtek-electronics)

## Its most-cited devices
- K212372: Fitbit Irregular Rhythm Notifications (2022), cited by 1
- DEN230050: Body Temperature Software (BTS) (2023), cited by 1

## Recent decisions
- K242967: Loss of Pulse Detection (Feb 25, 2025)
- K243778: Body Temperature Software (BTS) (Feb 13, 2025)
- DEN230050: Body Temperature Software (BTS) (Dec 15, 2023)
- K212372: Fitbit Irregular Rhythm Notifications (Apr 8, 2022)
- K200948: Fitbit ECG App (Sep 11, 2020)
- K133872: Aria Wifi Smart Scale (Jun 2, 2014)

Source page: https://510kreport.com/company/fitbit