510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212372Substantially Equivalent

Fitbit Irregular Rhythm Notifications

Fitbit LLC, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212372 is the FDA 510(k) clearance record for Fitbit Irregular Rhythm Notifications, a class II device, cleared for Fitbit, Inc. on under FDA product code QDB (Photoplethysmograph Analysis Software For Over-The-Counter Use). FDA's definition for product code QDB reads: "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". FDA records list 6 510(k) clearances for Fitbit, Inc., from to . As of , FDA records show no recalls naming K212372.

Clearance record

Decision date
Received
(252 days to decision)
Product code
QDB Photoplethysmograph Analysis Software For Over-The-Counter Use
Regulation
21 CFR 870.2790
Device class
Class II
Review panel
Cardiovascular
Applicant
Fitbit, Inc. 199 Fremont St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDB

Trailing 12 months

FDA records hold no clearances under product code QDB in the trailing twelve months.

FDA records show no clearances under product code QDB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260