510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894893Substantially Equivalent

Point Checker Color Strip Thermometer

Kyowa Medex Co., Ltd., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894893 is the FDA 510(k) clearance record for POINT CHECKER COLOR STRIP THERMOMETER, a class I device, cleared for Kyowa Medex Co., Ltd. on under FDA product code FQZ (Thermometer, Clinical Color Change). FDA records list one 510(k) clearance for Kyowa Medex Co., Ltd. As of , FDA records show no recalls naming K894893.

Clearance record

Decision date
Received
(247 days to decision)
Product code
FQZ Thermometer, Clinical Color Change
Regulation
21 CFR 880.2900
Device class
Class I
Review panel
General Hospital
Applicant
Kyowa Medex Co., Ltd. 1401 Wilson Blvd., Arlington VA
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