Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MGP — Predicate Candidate Screening
80 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
276 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012995 | COLLATEK SHEET | Biocore Medical Technologies, Inc. | 2001-10-25 | 49 | 0 |
| K012997 | COLLATEK FOAM | Biocore Medical Technologies, Inc. | 2001-10-25 | 49 | 0 |
| K001508 | LASERSKIN DRESSING | Fidia Advanced Biopolymers Srl | 2001-07-25 | 436 | 0 |
| K990079 | FASTSEAL CHEST WOUND DRESSING | Greenfield Medical Technologies, Inc. | 1999-12-23 | 346 | 0 |
| K991214 | SIMPLICARE TRANSPARENT WOUND DRESSING | Hollister, Inc. | 1999-10-14 | 188 | 0 |
| K992302 | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS | Dermaphylyx, Inc. | 1999-09-14 | 68 | 0 |
| K992005 | GILTECH PLUS TRANSPARENT DRESSING | Giltech Plus, Inc. | 1999-09-03 | 80 | 0 |
| K990875 | DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESS | Dermaphylyx, Inc. | 1999-05-27 | 72 | 0 |
| K990438 | DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEA | Dermaphylyx, Inc. | 1999-03-25 | 42 | 0 |
| K984371 | MEPITEL NON ADHERENT SILICONE DRESSING | Molnlycke Health Care, Inc. | 1999-03-03 | 86 | 0 |
| K983303 | INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCO | Innovative Technologies , Ltd. | 1998-12-09 | 79 | 0 |
| K983234 | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-25 | 71 | 0 |
| K983394 | MODIFICATION TO TIELLE HYDROPOLMER DRESSING | Johnson & Johnson Medical, Div. of Ethicon, Inc. | 1998-11-03 | 39 | 0 |
| K983184 | MEPILEX | Molnlycke Health Care, Inc. | 1998-10-28 | 47 | 0 |
| K974891 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 | Acutek Adhesive Specialties, Inc. | 1998-10-21 | 295 | 0 |
| K974890 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 | Acutek Adhesive Specialties, Inc. | 1998-10-13 | 287 | 0 |
| K982939 | BTF THIN FILM WOUND DRESSING | Bioderm, Inc. | 1998-10-13 | 53 | 0 |
| K974892 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 | Acutek Adhesive Specialties, Inc. | 1998-10-13 | 287 | 0 |
| K981713 | CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100 | Smith & Nephew, Inc. | 1998-07-31 | 77 | 0 |
| K981753 | INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FIL | Innovative Technologies , Ltd. | 1998-06-30 | 43 | 0 |
| K980209 | SIMPLICARE THIN FILM WOUND DRESSINGS | Hollister, Inc. | 1998-02-20 | 31 | 0 |
| K974520 | SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND | Innovative Technologies (Us), Inc. | 1998-02-06 | 66 | 0 |
| K973538 | N-TERFACE | Winfield Laboratories, Inc. | 1997-12-16 | 89 | 0 |
| K973657 | ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING | Maersk Medical, Ltd. | 1997-12-01 | 67 | 0 |
| K973036 | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DR | 3M Healthcare | 1997-11-12 | 90 | 0 |
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING | Polymedica Industries, Inc. | 1997-10-24 | 354 | 0 |
| K973312 | TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING | Innovative Technologies , Ltd. | 1997-10-22 | 49 | 0 |
| K973260 | HYDRASORB STERILE DRESSING | Avitar, Inc. | 1997-10-21 | 53 | 0 |
| K972458 | LYOCELL WOUND DRESSING/SURGICAL SPONGE | Courtaulds Fibers, Inc. | 1997-09-19 | 80 | 0 |
| K971093 | OPPORTUNITY I.V. START KIT | Opportunity, Inc. | 1997-09-16 | 176 | 0 |
| K970518 | ALGOPLAQUE HYDROCOLLOID DRESSING | Laboratoires Urgo S.A. | 1997-03-21 | 38 | 0 |
| K963753 | NASP TRANSPARENT DRESSING | North American Sterilization & Packaging Co. | 1996-11-29 | 72 | 0 |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | Polymedica Industries, Inc. | 1996-10-25 | 44 | 0 |
| K961319 | EPIVIEW | Convatec, A Division of E.R. Squibb & Sons | 1996-07-08 | 94 | 0 |
| K961098 | BIO-DRESSING, STERILE ISLAND DRESSING | K. W. Griffen Co. | 1996-05-03 | 45 | 0 |
| K960847 | DERMASEAL | Bellingham Medical, Inc. | 1996-04-04 | 43 | 0 |
| K960393 | SURESKIN BORDER | Euromed A/S | 1996-03-01 | 32 | 0 |
| K960404 | SURESKIN THIN | Euromed A/S | 1996-03-01 | 32 | 0 |
| K960394 | SURESKIN STANDARD | Euromed A/S | 1996-03-01 | 32 | 0 |
| K955476 | DUKAL TRANSPARENT WOUND DRESSING | Dukal Corp. | 1996-01-18 | 49 | 0 |
| K955383 | SPYROCOLLOID WOUND DRESSING | Polymedica Industries, Inc. | 1995-12-13 | 19 | 0 |
| K953885 | SPYROFLEX SKIN PROTECTOR | Polymedica Industries, Inc. | 1995-11-29 | 104 | 0 |
| K954602 | FLEXZAN WOUND DRESSING | Dow Hickam Pharmaceuticals, Inc. | 1995-11-02 | 36 | 0 |
| K954738 | DERMAGRAN HYDROPHILIC WOUND DRESSING | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954033 | TECNOL ISLAND WOUND DRESSING | Tecnol Medical Products, Inc. | 1995-09-22 | 25 | 0 |
| K953018 | UNI-SITE | Ttl Medical | 1995-09-08 | 71 | 0 |
| K953618 | SPYROFLEX WOUND DRESSING | Polymedica Industries, Inc. | 1995-08-21 | 18 | 0 |
| K952449 | TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSIN | Medical Device Development Co. | 1995-08-07 | 74 | 0 |
| K952504 | TECNOL TRANSPARENT WOUND DRESSING | Tecnol Medical Products, Inc. | 1995-07-26 | 57 | 0 |
| K952071 | ULTEC THIN HYDROCOLLOID DRESSING | Sherwood Medical Co. | 1995-06-22 | 51 | 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