KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

Leading manufacturers include Surgikos, Inc., Procter & Gamble Mfg. Co. and Deroyal Industries, Inc..

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
1–24 of 450
Cleared Oct 25, 2023
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645
Avery Dennison Medical , Ltd.
General Hospital · 231d
Cleared May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578
3M Company
General Hospital · 266d
Cleared Jul 30, 2021
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208
Avery Dennison Belgie Bvba
General Hospital · 358d
Cleared Apr 26, 2020
ControlRad Sterile Cover
K200238
Controlrad, Inc.
General Hospital · 86d
Cleared Sep 14, 2017
MediClear PreOp
K163556
Covalontechnologies, Inc.
General Hospital · 269d
Cleared Jun 24, 2015
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
K133080
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 632d
Cleared Apr 14, 2015
HONGYU DISPOSABLE SURGICAL DRAPES
K141324
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
General Hospital · 329d
Cleared Sep 10, 2014
SURGICAL DRAPE
K140195
Griffith-Lucas, LLC
General Hospital · 226d
Cleared Aug 18, 2014
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330
3M Healthcare
General Hospital · 189d
Cleared Aug 14, 2014
WHITNEY MEDICAL SOLUTIONS ESHIELD
K141438
Whitney Medical Solutions
General Hospital · 76d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250
3M Healthcare
General Hospital · 175d
Cleared Mar 12, 2014
SURGISLEEVE WOUND PROTECTOR
K140064
Covidien
General Hospital · 61d
Cleared Jan 31, 2014
AVD RIGHT RADIAL DRAPE
K131571
Advanced Vascular Dynamics
General Hospital · 246d
Cleared Jul 05, 2013
TIBURON SURGICAL DRAPE
K130404
Cardinal Health200, LLC
General Hospital · 136d
Cleared Jun 06, 2013
DAS MEDICAL EQUIPMENT DRAPES
K121436
Das Medical, LLC
General Hospital · 387d
Cleared Feb 14, 2013
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
K121919
Exact Medical Manufacturing, Inc.
General Hospital · 227d
Cleared Dec 12, 2012
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
K122000
Changzhou Holymed Products Co., Ltd.
General Hospital · 156d
Cleared May 08, 2012
COBES SURGICAL DRAPE
K112378
Cobes Industries Co., Ltd.
General Hospital · 264d
Cleared Dec 01, 2011
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
K111458
Gri Medical & Electronic Technology Co., Ltd.
General Hospital · 189d
Cleared Sep 29, 2011
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
K112136
Kunshan Jiehong Nonwoven Product Co., Ltd.
General Hospital · 65d
Cleared Nov 09, 2010
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666
Kimberly-Clark Corp.
General Hospital · 55d
Cleared May 06, 2010
BUSSE SURGICAL DRAPES IV
K093909
Busse Hospital Disposables, Inc.
General Hospital · 135d
Cleared Oct 09, 2009
BUSSE SURGICAL DRAPES III
K092212
Busse Hospital Disposables, Inc.
General Hospital · 79d
Cleared Mar 25, 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234
Kimberly-Clark Corp.
General Hospital · 142d

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.