Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KKX — Predicate Candidate Screening
450 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
242 days90th percentile
450clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | 2023-10-25 | 231 | 0 |
| K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contain | 3M Company | 2023-05-18 | 266 | 0 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 | 358 | 0 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 | 86 | 0 |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 | 269 | 0 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 | 632 | 0 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 | 329 | 0 |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | 2014-09-10 | 226 | 0 |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | 2014-08-18 | 189 | 0 |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | 2014-08-14 | 76 | 0 |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | 2014-07-25 | 175 | 0 |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | 2014-03-12 | 61 | 0 |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | 2014-01-31 | 246 | 0 |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | 2013-07-05 | 136 | 0 |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | 2013-06-06 | 387 | 0 |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | 2013-02-14 | 227 | 0 |
| K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | Changzhou Holymed Products Co., Ltd. | 2012-12-12 | 156 | 0 |
| K112378 | COBES SURGICAL DRAPE | Cobes Industries Co., Ltd. | 2012-05-08 | 264 | 0 |
| K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQU | Gri Medical & Electronic Technology Co., Ltd. | 2011-12-01 | 189 | 0 |
| K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STER | Kunshan Jiehong Nonwoven Product Co., Ltd. | 2011-09-29 | 65 | 0 |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLU | A Plus International, Inc. | 2011-01-13 | 105 | 0 |
| K101350 | RADSCAN EQUIPMENT SLICKER | Radscan Medical Equipment, Inc. | 2011-01-04 | 235 | 0 |
| K094016 | NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATIO | Hinson and Hale Medical Technologies, Inc. | 2010-11-19 | 325 | 0 |
| K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVE | Kimberly-Clark Corp. | 2010-11-09 | 55 | 0 |
| K100991 | IMC SURGICAL DRAPE | International Medsurg Connection | 2010-10-05 | 179 | 0 |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR D | Exact Medical Manufacturing, Inc. | 2010-10-04 | 118 | 0 |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | Exact Medical Manufacturing, Inc. | 2010-09-20 | 96 | 0 |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | Exact Medical Manufacturing, Inc. | 2010-09-20 | 96 | 0 |
| K093909 | BUSSE SURGICAL DRAPES IV | Busse Hospital Disposables, Inc. | 2010-05-06 | 135 | 0 |
| K100208 | IMC SURGICAL DRAPE | International Medsurg Connection | 2010-04-20 | 85 | 0 |
| K092212 | BUSSE SURGICAL DRAPES III | Busse Hospital Disposables, Inc. | 2009-10-09 | 79 | 0 |
| K091343 | MRI NEURO DRAPE | Surgivision, Inc. | 2009-09-22 | 139 | 0 |
| K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY | Kimberly-Clark Corp. | 2009-03-25 | 142 | 2 |
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Dukal Corp. | 2009-03-06 | 114 | 0 |
| K083424 | BUSSE SURGICAL DRAPE | Busse Hosipital Disposables | 2009-02-26 | 99 | 0 |
| K082297 | BUSSE SURGICAL DRAPE | Busse Hospital Disposables, Inc. | 2008-12-09 | 119 | 0 |
| K080796 | SRI LP DRAPE | Sri/Surgical Express | 2008-11-17 | 242 | 0 |
| K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND C | Promedical Products Co., Ltd. | 2008-10-20 | 229 | 0 |
| K081476 | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE | Surgical Concept Designs | 2008-08-08 | 73 | 0 |
| K080341 | ENDODRAPE(TM) | Vortek Surgical, LLC | 2008-07-21 | 164 | 0 |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | Arrow Intl., Inc. | 2007-10-10 | 133 | 0 |
| K070432 | GENERAL SURGERY DRAPES | Welmed, Inc. | 2007-09-24 | 223 | 0 |
| K070406 | ENDODRAPE | Vortek Surgical, LLC | 2007-07-30 | 168 | 0 |
| K062480 | JOYKEY SURGICAL DRAPES (STERILE) | Joykey Industryial , Ltd. | 2007-03-05 | 193 | 0 |
| K061422 | SURGICAL DRAPES | Austin Medical, Inc. | 2006-09-25 | 125 | 0 |
| K061762 | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N | Cardinal Health, Inc. | 2006-08-01 | 40 | 0 |
| K052668 | OR SPECIFIC BIG CASE BACK TABLE COVER | Or Specific, Inc. | 2006-07-24 | 300 | 0 |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | Microtek Medical, Inc. | 2006-05-31 | 125 | 0 |
| K053495 | EQUIPMENT SLUSH DRAPE | Advance Medical Designs, Inc. | 2006-03-16 | 91 | 0 |
| K052833 | GORE-TEX NON-STERILE SURGICAL GOWNS | Medline Industries, Inc. | 2006-02-15 | 132 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda