510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994199Substantially Equivalent

Various Sterile and Non-Sterile Surgical Drapes, (I.e., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor

Custom Medical Products, Ltd., Asheville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994199 is the FDA 510(k) clearance record for VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR, a class II device, cleared for Custom Medical Products, Inc. on under FDA product code KKX (Drape, Surgical, Antimicrobial). FDA's definition for product code KKX reads: "Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI". FDA records list 14 510(k) clearances for Custom Medical Products, Inc., from to . As of , FDA records show no recalls naming K994199.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Custom Medical Products, Inc. 1 Holiday Inn Dr., Asheville NC
510(k) summary
Statement
Third party review
No

Clearances, product code KKX

Trailing 12 months

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

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