510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771038Substantially Equivalent

Thermometer, Single Use, Strip, Tempadot

Organon LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771038 is the FDA 510(k) clearance record for THERMOMETER, SINGLE USE, STRIP, TEMPADOT, a class I device, cleared for Organon, Inc. on under FDA product code FQZ (Thermometer, Clinical Color Change). FDA records list 42 510(k) clearances for Organon, Inc., from to . As of , FDA records show no recalls naming K771038.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FQZ Thermometer, Clinical Color Change
Regulation
21 CFR 880.2900
Device class
Class I
Review panel
General Hospital
Applicant
Organon, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FQZ

Trailing 12 months

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

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