510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801256Substantially Equivalent

Needle Counter-Sure Count-Disposa-Tray

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

K801256 is the FDA 510(k) clearance record for NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY, a class I device, cleared for Kleen Test Products on under FDA product code BXX (Calibrator, Pressure, Gas). FDA records list 17 510(k) clearances for Kleen Test Products, from to . As of , FDA records show no recalls naming K801256.

Clearance record

Decision date
Received
(7 days to decision)
Product code
BXX Calibrator, Pressure, Gas
Regulation
21 CFR 868.2620
Device class
Class I
Review panel
Anesthesiology
Applicant
Kleen Test Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXX

Trailing 12 months

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

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