Cleared Traditional

Fitbit Irregular Rhythm Notifications

K212372 · Fitbit, Inc. · Cardiovascular
Apr 2022
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K212372 is an FDA 510(k) clearance for the Fitbit Irregular Rhythm Notifications, a Photoplethysmograph Analysis Software For Over-the-counter Use (Class II — Special Controls, product code QDB), submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 8, 2022, 252 days after receiving the submission on July 30, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2790.

Submission Details

510(k) Number K212372 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2021
Decision Date April 08, 2022
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QDB — Photoplethysmograph Analysis Software For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2790
Definition 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.