Fitbit Irregular Rhythm Notifications

FDA 510(k) K212372 · Fitbit, Inc.

Substantially Equivalent

510(k) numberK212372

Submission

Device name
Fitbit Irregular Rhythm Notifications
Applicant
Fitbit, Inc.
San Francisco, CA, US
Received
July 30, 2021
Decision date
April 8, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2790
Specialty
Cardiovascular

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 510(k)s with product code QDB

510(k)DeviceApplicantDecision
K231173Irregular Rhythm Notification Feature (IRNF)QDB · Traditional Apple, Inc.07/21/2023SE
K213971Atrial Fibrillation History FeatureQDB · Traditional Apple, Inc.06/03/2022SE
K212516IRNF AppQDB · Traditional Apple, Inc.10/22/2021SE

More from Apple, Inc.

510(k)DeviceDecision
K242967Loss of Pulse DetectionSDY · Traditional 02/25/2025SE
K243778Body Temperature Software (BTS)QZA · Special 02/13/2025SE
K200948Fitbit ECG AppQDA · Traditional 09/11/2020SE
K133872Aria Wifi Smart ScaleMNW · Traditional 06/02/2014SE

Questions and answers

When was Fitbit Irregular Rhythm Notifications cleared by the FDA?

Fitbit Irregular Rhythm Notifications (K212372) received a 510(k) decision of Substantially Equivalent on April 8, 2022, 252 days after the submission was received.

What is the product code of K212372?

The FDA product code is QDB – Photoplethysmograph Analysis Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2790.