Atlas FDA

KKX

450 FDA 510(k) clearances · Product code

73 daysmedian time to decision
242 days90th percentile
450clearances measured

FDA profile

Official device name
Drape, Surgical, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
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.
Adverse events (MAUDE)
2020: 16 · 2021: 41 · 2022: 19 · 2023: 32 · 2024: 19 · 2025: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BeneHold™ Surgical Incise Drape with CHG antimicrobial II (K230645)Avery Dennison Medical , Ltd.2023-10-25
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578)3M Company2023-05-18
BeneHold Surgical Incise Drape with CHG antimicrobial (K202208)Avery Dennison Belgie Bvba2021-07-30
ControlRad Sterile Cover (K200238)Controlrad, Inc.2020-04-26
MediClear PreOp (K163556)Covalontechnologies, Inc.2017-09-14
Plus Surgical Drapes (EO Sterilized), PMDB-XXX (K133080)Foshan Nanhai Plus Medical Co, Ltd.2015-06-24
HONGYU DISPOSABLE SURGICAL DRAPES (K141324)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
SURGICAL DRAPE (K140195)Griffith-Lucas, LLC2014-09-10
3M STERI-DRAPE FABRIC SURGICAL DRAPES (K140330)3M Healthcare2014-08-18
WHITNEY MEDICAL SOLUTIONS ESHIELD (K141438)Whitney Medical Solutions2014-08-14
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (K140250)3M Healthcare2014-07-25
SURGISLEEVE WOUND PROTECTOR (K140064)Covidien2014-03-12
AVD RIGHT RADIAL DRAPE (K131571)Advanced Vascular Dynamics2014-01-31
TIBURON SURGICAL DRAPE (K130404)Cardinal Health200, LLC2013-07-05
DAS MEDICAL EQUIPMENT DRAPES (K121436)Das Medical, LLC2013-06-06
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV (K121919)Exact Medical Manufacturing, Inc.2013-02-14
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER (K122000)Changzhou Holymed Products Co., Ltd.2012-12-12
COBES SURGICAL DRAPE (K112378)Cobes Industries Co., Ltd.2012-05-08
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS (K111458)Gri Medical & Electronic Technology Co., Ltd.2011-12-01
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE (K112136)Kunshan Jiehong Nonwoven Product Co., Ltd.2011-09-29
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) (K102861)A Plus International, Inc.2011-01-13
RADSCAN EQUIPMENT SLICKER (K101350)Radscan Medical Equipment, Inc.2011-01-04
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H (K094016)Hinson and Hale Medical Technologies, Inc.2010-11-19
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM (K102666)Kimberly-Clark Corp.2010-11-09
IMC SURGICAL DRAPE (K100991)International Medsurg Connection2010-10-05
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) (K101598)Exact Medical Manufacturing, Inc.2010-10-04
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 (K101688)Exact Medical Manufacturing, Inc.2010-09-20
EMM EQUIPMENT COVER-POLYTHYLENE (K101689)Exact Medical Manufacturing, Inc.2010-09-20
BUSSE SURGICAL DRAPES IV (K093909)Busse Hospital Disposables, Inc.2010-05-06
IMC SURGICAL DRAPE (K100208)International Medsurg Connection2010-04-20
BUSSE SURGICAL DRAPES III (K092212)Busse Hospital Disposables, Inc.2009-10-09
MRI NEURO DRAPE (K091343)Surgivision, Inc.2009-09-22
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 (K083234)Kimberly-Clark Corp.2009-03-25
DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (K083320)Dukal Corp.2009-03-06
BUSSE SURGICAL DRAPE (K083424)Busse Hosipital Disposables2009-02-26
BUSSE SURGICAL DRAPE (K082297)Busse Hospital Disposables, Inc.2008-12-09
SRI LP DRAPE (K080796)Sri/Surgical Express2008-11-17
PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS (K080629)Promedical Products Co., Ltd.2008-10-20
SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE (K081476)Surgical Concept Designs2008-08-08
ENDODRAPE(TM) (K080341)Vortek Surgical, LLC2008-07-21
ARROW INTERNATIONAL, INC., SURGICAL DRAPES (K071491)Arrow Intl., Inc.2007-10-10
GENERAL SURGERY DRAPES (K070432)Welmed, Inc.2007-09-24
ENDODRAPE (K070406)Vortek Surgical, LLC2007-07-30
JOYKEY SURGICAL DRAPES (STERILE) (K062480)Joykey Industryial , Ltd.2007-03-05
SURGICAL DRAPES (K061422)Austin Medical, Inc.2006-09-25
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N (K061762)Cardinal Health, Inc.2006-08-01
OR SPECIFIC BIG CASE BACK TABLE COVER (K052668)Or Specific, Inc.2006-07-24
MICROTEK MEDICAL WARMING DRAPE (K060200)Microtek Medical, Inc.2006-05-31
EQUIPMENT SLUSH DRAPE (K053495)Advance Medical Designs, Inc.2006-03-16
GORE-TEX NON-STERILE SURGICAL GOWNS (K052833)Medline Industries, Inc.2006-02-15
STERILE EQUIPMENT COVERS (K052395)Volcano Corporation2005-12-01
IMC SURGICAL DRAPES (K052169)International Medsurg Connection, Inc.2005-11-17
3L SURGICAL DRAPES (K043015)3l Medical Products Co., Ltd.2005-08-15
BARRIER SURGICAL DRAPES (K051625)Molnlycke Health Care, Inc.2005-07-14
IMC DRAPES (K050538)Intl. Medsurg Connection, Inc.2005-06-07
MICROTEK EQUIPMENT DRAPES (K050322)Microtek Medical, Inc.2005-05-17
LASIK EYE DRAPE (K042977)Odyssey Medical, Inc.2005-05-10
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES (K050508)Haywood Vocational Opportunities2005-04-27
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX (K042526)Medical Action Industries, Inc.2005-04-25
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES (K032666)Medline Industries, Inc.2005-03-16
UNDER BUTTOCKS DRAPE (K042893)International Medsurg Connection, Inc.2005-03-11
FOOTHILLS SURGICAL DRAPES (K041224)Foothills Industries, Inc.2005-02-03
PROMEDICAL SURGICAL DRAPES (K042131)Promedical Products Co., Ltd.2004-12-10
PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS (K042137)Promedical Products Co., Ltd.2004-10-05
SABRESOURCE DRAPE (K041846)Minrad, Inc.2004-08-26
IMALUX OCT PROBE GUIDE (K041077)Imalux Corporation2004-06-25
ALEXIS WOUND RETRACTOR (K031889)Applied Medical Resources Corp.2003-09-22
STERI-DRAPE SURGICAL DRAPES (K031287)3M Company2003-09-10
DEROYAL SURGICAL DRAPES BACKTABLE COVER (K030908)Deroyal2003-08-11
KLINIDRAPE SURGICAL DRAPES (K031131)Molnlycke Health Care2003-06-10
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS (K031362)Lac Mac, Ltd.2003-05-30
DEROYAL DRAPES, STERILE, NON-STERILE (K030365)Deroyal Industries, Inc.2003-04-29
TRILAMINATE DRAPES/TIBURON (K023419)Allegiance Healthcare Corp.2003-02-11
PRIMAGARD SURGICAL EQUIPMENT DRAPES (K022868)Primeline Medical Products, Inc.2002-11-08
PRIMAGARD SURGICAL GOWNS (K023117)Primeline Medical Products, Inc.2002-11-08
DRAPES WITH ABSORBENT REINFORCEMENT (K023425)Allegiance Healthcare Corp.2002-11-06
MEDLINE ASEP PLUS SURGICAL DRAPES (K023432)Medline Industries, Inc.2002-11-04
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) (K021864)Primeline Medical Products, Inc.2002-09-23
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 (K020581)Medical Concepts Development, Inc.2002-09-18
INDUS TEXTILES TOWEL-STERILE AND NON-STERILE (K013958)Indus Textiles, Inc.2002-08-19
MASTER & FRANK SURGICAL DRAPES (STERILE) (K020393)Master & Frank Enterprses Co., Ltd.2002-05-03
WOUND PROTECTOR/RETRACTOR (K020435)Applied Medical Resources Corp.2002-04-15
TOWEL DRAPE, MODELS 4409, 4410 (K012957)Dynarex Corp.2002-03-06
MERTEX-PLUS REUSABLE SURGICAL DRAPE (K012237)Mercan AB2001-10-15
MODIFICATION TO: COMPEL SURGICAL DRAPES (K012807)Standard Textile Co., Inc.2001-10-11
ADVANCE MEDICAL DESIGNS FLUID POUCH (K012168)Advance Medical Designs, Inc.2001-09-18
SURGICAL DRAPES (K011422)Advance Medical Designs, Inc.2001-07-10
ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR (K010711)Advanced Surgical Concepts (Asc)2001-05-22
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX (K000442)Medical Concepts Development, Inc.2001-04-24
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE (K010572)Becton, Dickinson and Co.2001-03-12
PATIENT DRAPE, SURGICAL (K003670)Advance Medical Designs, Inc.2001-01-26
COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE (K002691)Com-Med International, Inc.2000-12-08
NEUROTOLOGY DRAPE, MODEL TBD (K002702)Gyrus Ent LLC2000-10-26
EQUIPMENT DRAPES (K002508)Allegiance Healthcare Corp.2000-09-01
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE (K001858)China Nantong Guangda Textile Co., Ltd.2000-08-17
SURGICAL DRAPES (K002419)Allegiance Healthcare Coporation2000-08-15
EEI SLUSH PAN DRAPE (K001994)Eagle Endoscopic, Inc.2000-08-04
KLINIDRAPE SURGICAL DRAPES (K000906)Molnlycke Health Care, Inc.2000-06-23
RESOLVE SURGICAL O.R. TOWELS (K001667)Allegiance Healthcare Corp.2000-06-23
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR (K994199)Custom Medical Products, Inc.2000-06-09
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Every clearance here is in the API, with alerts when new ones post.