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
K760428Substantially Equivalent

Suture Rack & Needle Counter

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

K760428 is the FDA 510(k) clearance record for SUTURE RACK & NEEDLE COUNTER, a class I device, cleared for Kleen Test Products on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 17 510(k) clearances for Kleen Test Products, from to . As of , FDA records show no recalls naming K760428.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kleen Test Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FSM

Trailing 12 months

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

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