510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242967Substantially Equivalent

Loss of Pulse Detection

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

K242967 is the FDA 510(k) clearance record for Loss of Pulse Detection, a class II device, cleared for Fitbit on under FDA product code SDY (Loss Of Pulse Notification Software). FDA's definition for product code SDY reads: "A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying loss of pulse. This device is not intended to provide a diagnosis". FDA records list 6 510(k) clearances for Fitbit, from to . As of , FDA records show no recalls naming K242967.

Clearance record

Decision date
Received
(152 days to decision)
Product code
SDY Loss Of Pulse Notification Software
Regulation
21 CFR 870.2790
Device class
Class II
Review panel
Cardiovascular
Applicant
Fitbit 215 Fremont St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SDY

Trailing 12 months

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

FDA records show no clearances under product code SDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDY, 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