Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NAD — Predicate Candidate Screening
107 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
191 days90th percentile
107clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 | 191 | 0 |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 | 30 | 0 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 | 280 | 0 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 | 57 | 0 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 | 52 | 0 |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | 2005-03-24 | 139 | 0 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 | 56 | 0 |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 | 346 | 1 |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 | 27 | 0 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 | 148 | 0 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING | Dumex Medical Surgical Products, Ltd. | 1996-04-29 | 61 | 0 |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 | 77 | 0 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 | 82 | 0 |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 | 134 | 0 |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 | 87 | 0 |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 | 89 | 0 |
| K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | Johnson & Johnson Medical, Inc. | 1991-01-28 | 279 | 0 |
| K901378 | TENSOPLUS LITE | Smith & Nephew United, Inc. | 1990-06-12 | 82 | 0 |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | 1990-02-21 | 57 | 0 |
| K895654 | SORBEX(TM) SOFT SPONGE | Fountain Pharmaceuticals, Inc. | 1990-02-20 | 153 | 0 |
| K895817 | HERMAL WOUND CARE KIT | Stiefel Research Institute, Inc. | 1990-01-19 | 112 | 0 |
| K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING | Advance Medical Designs, Inc. | 1989-11-01 | 29 | 0 |
| K894254 | HYPAFIX DRESSING RETENTION SHEET | Smith & Nephew United, Inc. | 1989-08-31 | 72 | 0 |
| K892837 | STERIL-DERM TRANSPARENT WOUND DRESSING | Biointerface Technologies, Inc. | 1989-08-01 | 105 | 0 |
| K891998 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED, 37X37X52 | Elwyn Industries | 1989-06-05 | 69 | 0 |
| K891459 | STERILE BURNNET PRE-CUT (VARIOUS SIZES) | Western Medical, Ltd. | 1989-05-26 | 72 | 0 |
| K882558 | AREOLA/NIPPLE DRESSING | Cooper Surgical/Aesthete | 1989-05-24 | 337 | 0 |
| K890603 | BEAM TECH WOUND DRESSING* | Beam Tech , Ltd. | 1989-05-23 | 106 | 0 |
| K892527 | DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY | Convatec, A Division of E.R. Squibb & Sons | 1989-05-11 | 30 | 0 |
| K891696 | DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1989-05-04 | 43 | 0 |
| K884791 | PERME-AID TRANSPARENT DRESSING, #11XX | Nitto Denko Technical Corp. | 1989-05-04 | 170 | 0 |
| K890354 | TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X | 3M Company | 1989-04-27 | 93 | 0 |
| K890940 | MODIFIED LABELING FOR POLYDERM WBC(TM) | Laivan Corp. | 1989-04-17 | 54 | 0 |
| K885325 | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES | Frastec Wound Care Products, Inc. | 1989-04-17 | 110 | 0 |
| K883391 | POLYMER ADHESIVE BANDAGE | Marion Laboratories, Inc. | 1989-03-23 | 226 | 0 |
| K890748 | ALLEVYN TRACHEOSTOMY DRESSING | Smith & Nephew United, Inc. | 1989-03-08 | 23 | 0 |
| K883849 | REPLICARE (ADDITIONAL CLAIMS) | United Medical | 1989-02-08 | 149 | 0 |
| K884440 | TECNOL VARIABLE TENSION BANDAGE | Tecnol New Jersey Wound Care, Inc. | 1989-01-17 | 88 | 0 |
| K881426 | PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGE | Laboratoire Pan-Pra | 1988-11-10 | 219 | 0 |
| K881731 | AD-HEAL(TM) WOUND DRESSING | Nepera, Inc. | 1988-08-31 | 131 | 0 |
| K881936 | OPER-FILM-ADHESIVE MEMBRANE | Iberhospitex, S.A. | 1988-08-31 | 114 | 0 |
| K882696 | DERMICEL, MONTGOMERY STRAP | Bioseal | 1988-08-26 | 60 | 0 |
| K881988 | 3M WOUND CONTACT MATERIAL, PRODUCT #563X | 3M Company | 1988-06-27 | 46 | 0 |
| K875253 | BFGOODRICH BIOTHANE NON-ADHERENT DRESSING | The Bfgoodrich Co. | 1988-04-13 | 113 | 0 |
| K880153 | POLYDERM A+B(TM) | Laivan Corp. | 1988-04-13 | 91 | 0 |
| K881050 | DUODERM(R) CGF | Convatec, A Division of E.R. Squibb & Sons | 1988-04-01 | 21 | 0 |
| K874554 | ENVICLUSIVE (TM) | Marion Laboratories, Inc. | 1988-03-11 | 128 | 0 |
| K880206 | POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER | Laivan Corp. | 1988-03-11 | 56 | 0 |
| K872573 | PHARMACLUSIVE (TM) | Pharmacia, Inc. | 1988-02-29 | 245 | 0 |
| K874480 | MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM) | Omikron Scientific, Ltd. | 1988-02-22 | 112 | 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