Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AlphabetLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Fitbit with 5 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Feb 25, 2025: Loss of Pulse Detection.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 25, 2025 | Loss of Pulse DetectionK242967 · SDY | 510(k) clearances |
| Feb 25, 2025 | Loss of Pulse DetectionK242967 · Cardiovascular | AI-enabled devices |
| Feb 13, 2025 | Body Temperature Software (BTS)K243778 · QZA | 510(k) clearances |
| Dec 15, 2023 | Body Temperature Software (BTS)DEN230050 · QZA | 510(k) clearances |
| Apr 8, 2022 | Fitbit Irregular Rhythm NotificationsK212372 · QDB | 510(k) clearances |
| Sep 11, 2020 | Fitbit ECG AppK200948 · QDA | 510(k) clearances |
| Jun 2, 2014 | ARIA WIFI SMART SCALEK133872 · MNW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
