FDA applicant

Fitbit, Inc.

San Francisco, CA6 decisions2014–20250 recalls

FDA records 6 decisions for Fitbit, Inc. (San Francisco, CA) from 2014 to 2025: 5 510(k) clearances and 1 De Novo grant. Most are in product codes QZA (Body Temperature Sensing Software) and SDY (Loss Of Pulse Notification Software). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fitbit, LLC”, “Fitbit”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Fitbit, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2014high 2 (2025) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Fitbit, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fitbit, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Fitbit, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?