KKX · Class II · 21 CFR 878.4370

FDA Product Code KKX: Drape, Surgical

Leading manufacturers include Surgikos, Inc., Procter & Gamble Mfg. Co. and Customed, 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 Mar 12, 2014
SURGISLEEVE WOUND PROTECTOR
K140064
Covidien
General Hospital · 61d
Cleared Nov 09, 2010
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666
Kimberly-Clark Corp.
General Hospital · 55d
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
Cleared Oct 10, 2007
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491
Arrow Intl., Inc.
General Hospital · 133d
Cleared Feb 15, 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833
Medline Industries, Inc.
General Hospital · 132d
Cleared Dec 01, 2005
STERILE EQUIPMENT COVERS
K052395
Volcano Corporation
General Hospital · 92d
Cleared Mar 16, 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666
Medline Industries, Inc.
General Hospital · 566d
Cleared Sep 22, 2003
ALEXIS WOUND RETRACTOR
K031889
Applied Medical Resources Corp.
General Hospital · 96d
Cleared Sep 10, 2003
STERI-DRAPE SURGICAL DRAPES
K031287
3M Company
General Hospital · 140d
Cleared Apr 29, 2003
DEROYAL DRAPES, STERILE, NON-STERILE
K030365
Deroyal Industries, Inc.
General Hospital · 84d
Cleared Feb 11, 2003
TRILAMINATE DRAPES/TIBURON
K023419
Allegiance Healthcare Corp.
General Hospital · 123d
Cleared Nov 06, 2002
DRAPES WITH ABSORBENT REINFORCEMENT
K023425
Allegiance Healthcare Corp.
General Hospital · 26d
Cleared Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432
Medline Industries, Inc.
General Hospital · 20d
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435
Applied Medical Resources Corp.
General Hospital · 66d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Feb 04, 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211
Dentsply Intl.
General Hospital · 52d
Cleared Jan 12, 2000
CONVERTORS SURGICAL DRAPES
K993795
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818
Allegiance Healthcare Corp.
General Hospital · 49d

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.