510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890539Substantially Equivalent

Sure Count Light Handle Cover

Kleen Test Products Corporation, Elkhorn WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890539 is the FDA 510(k) clearance record for SURE COUNT LIGHT HANDLE COVER, a class II device, cleared for Kleen Test Products on under FDA product code FTA (Light, Surgical, Accessories). FDA records list 17 510(k) clearances for Kleen Test Products, from to . As of , FDA records show no recalls naming K890539.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FTA Light, Surgical, Accessories
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kleen Test Products P.O. Box 140, Elkhorn WI
Third party review
No

Clearances, product code FTA

Trailing 12 months

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

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