FDA Product Code KKX: Drape, Surgical
Leading manufacturers include Medline Industries, Inc., Baxter Healthcare Corp and 3M Company.
450
Total
450
Cleared
109d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Drape, Surgical Devices (Product Code KKX)
450 devices
Cleared
Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
Avery Dennison Medical , Ltd.
General Hospital
231d
Cleared
May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
3M Company
General Hospital
266d
Cleared
Jul 30, 2021
BeneHold Surgical Incise Drape with CHG antimicrobial
Avery Dennison Belgie Bvba
General Hospital
358d
Cleared
Apr 26, 2020
ControlRad Sterile Cover
Controlrad, Inc.
General Hospital
86d
Cleared
Feb 15, 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
Medline Industries, Inc.
General Hospital
132d
Cleared
Mar 16, 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
Medline Industries, Inc.
General Hospital
566d
Cleared
Sep 10, 2003
STERI-DRAPE SURGICAL DRAPES
3M Company
General Hospital
140d
Cleared
Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
Medline Industries, Inc.
General Hospital
20d
Cleared
Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
Dentsply Intl.
General Hospital
52d
Cleared
Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
Medline Industries, Inc.
General Hospital
132d
Cleared
Nov 26, 1996
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
Medline Industries, Inc.
General Hospital
172d
Cleared
Nov 07, 1994
CONVERTORS ISO BAC DRAPE MATERIAL
Baxter Healthcare Corp
General Hospital
609d
Cleared
Jul 27, 1994
GLOBAL SHOULDER O.R. DRAPE PACK
Depuy, Inc.
General Hospital
134d
Cleared
Apr 26, 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
Baxter Healthcare Corp
General Hospital
69d
Cleared
Apr 11, 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
Baxter Healthcare Corp
General Hospital
606d
Cleared
Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
Baxter Healthcare Corp
General Hospital
65d
Cleared
Dec 17, 1987
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
3M Company
General Hospital
71d
Cleared
Oct 23, 1987
LASER RESISTANT DRAPE
Baxter Healthcare Corp
General Hospital
74d
Cleared
Jul 28, 1987
OPSITE SPECIALITY DRAPES
Smith & Nephew, Inc.
General Hospital
15d
Cleared
Sep 17, 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
3M Company
General Hospital
441d
Cleared
Jun 20, 1979
ACCU-SORB STERILE STOCKINETTES
Medline Industries, Inc.
General Hospital
8d
Cleared
Mar 23, 1977
UNDER BOTTOCKS DRAPE
C.R. Bard, Inc.
General Hospital
135d
About Product Code KKX - Regulatory Context
510(k) Submission Activity
450 total 510(k) submissions under product code KKX since 1976, with 450 receiving FDA clearance (average review time: 109 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.