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510(k) K212372

Fitbit Irregular Rhythm Notifications by Fitbit, Inc. — Product Code QDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2022
Date Received
July 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photoplethysmograph Analysis Software For Over-The-Counter Use
Device Class
Class II
Regulation Number
870.2790
Review Panel
CV
Submission Type

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Other clearances by Fitbit, Inc.

  • K242967 — Loss of Pulse Detection (February 25, 2025)
  • K243778 — Body Temperature Software (BTS) (February 13, 2025)
  • DEN230050 — Body Temperature Software (BTS) (December 15, 2023)
  • K200948 — Fitbit ECG App (September 11, 2020)
  • K133872 — ARIA WIFI SMART SCALE (June 2, 2014)

Other clearances for product code QDB

  • K231173 — Irregular Rhythm Notification Feature (IRNF) (July 21, 2023)
  • K213971 — Atrial Fibrillation History Feature (June 3, 2022)
  • K212516 — IRNF App (October 22, 2021)
  • DEN180042 — Irregular Rhythm Notification Feature (September 11, 2018)