KKXClass II

Drape, Surgical, Antimicrobial

21 CFR 878.4370 / General, Plastic Surgery

KKX is the FDA product code for Drape, Surgical, Antimicrobial, a class II device type, regulated under 21 CFR 878.4370. FDA's definition for this code 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". As of 2026-09-10, FDA records hold 450 510(k) clearances under this code, the most recent dated 2023-10-25, and 91 recalls.

Classification record

Product code: KKX
Device name: Drape, Surgical, Antimicrobial
FDA definition: 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.
Regulation: 21 CFR 878.4370
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 450
Ingested recalls: 91

Clearances, product code KKX

By decision year

450 clearances under product code KKX with a decision year between 1976 and 2023, 1980 the highest year at 27.

Show the numbers

510(k) clearances under FDA product code KKX by decision year
Year	Clearances
1976	7
1977	11
1978	19
1979	26
1980	27
1981	9
1982	10
1983	8
1984	12
1985	9
1986	21
1987	12
1988	10
1989	14
1990	21
1991	27
1992	23
1993	13
1994	21
1995	18
1996	9
1997	11
1998	6
1999	3
2000	12
2001	8
2002	10
2003	7
2004	4
2005	12
2006	6
2007	4
2008	5
2009	5
2010	8
2011	4
2012	2
2013	3
2014	6
2015	2
2017	1
2020	1
2021	1
2023	2

Applicants with the most clearances

Product code KKX

Applicants holding the most 510(k) clearances under product code KKX
Applicant	Clearances
Surgikos, Inc.	30
Procter & Gamble Mfg. Co.	14
Medtronic, Inc.	11
Customed, Inc	11
DeRoyal Industries, Inc.	11
Kimberly-Clark Corporation	8
Trinity Laboratories, Inc.	8
Graham Medical Products	6
Intl. Medsurg Connection, Inc.	6
MEDLINE INDUSTRIES, LP - Northfield	6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 183 companies shown, in name order