510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945055Substantially Equivalent

Harken Assure Self-Seal Sterilization Pouch

Harken Products, Inc., Irwindall CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945055 is the FDA 510(k) clearance record for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH, a class II device, cleared for Harken Products, Inc. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list one 510(k) clearance for Harken Products, Inc. As of , FDA records show no recalls naming K945055.

Clearance record

Decision date
Received
(61 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Harken Products, Inc. 15709 Arrow Hwy., Suite 5, Irwindall CA
510(k) summary
Summary
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 clearances under product code KCT in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20260