510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243778Substantially Equivalent

Body Temperature Software (BTS)

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

K243778 is the FDA 510(k) clearance record for Body Temperature Software (BTS), a class II device, cleared for Fitbit, LLC on under FDA product code QZA (Body Temperature Sensing Software). FDA's definition for product code QZA reads: "Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data". FDA records list 6 510(k) clearances for Fitbit, LLC, from to . As of , FDA records show no recalls naming K243778.

Clearance record

Decision date
Received
(66 days to decision)
Product code
QZA Body Temperature Sensing Software
Regulation
21 CFR 880.2915
Device class
Class II
Review panel
General Hospital
Applicant
Fitbit, LLC 215 Fremont St., San Francisco CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZA

Trailing 12 months

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

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