Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NAE — Predicate Candidate Screening

29 FDA 510(k) clearances under this product code; the 50 most recent screened below.

89 daysmedian FDA review time

247 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K083721	MODIFICATION TO ZENIEVA	River'S Edge Pharmaceuticals, LLC	2009-01-08	24
K082865	MODIFICATION TO ZENIEVA	Gorbec Pharmaceutical Services, Inc.	2008-10-23	24
K073246	ZENIEVA	Gorbec Pharmaceutical Services, Inc.	2008-07-23	247
K992094	GILTECH PLUS HYDROGEL SKIN DRESSING	Giltech Plus, Inc.	1999-09-17	88
K991061	DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING	Dermaphylyx, Inc.	1999-06-28	90
K972646	AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES	Ludlow Technical Products	1997-08-21	37
K971597	COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)	Coloplast Corp.	1997-07-29	89
K962352	HYDROGEL SKIN DRESSING	North American Sterilization & Packaging Co.	1996-08-02	45
K952945	AQUAFLO HYDROGEL WOUND DRESSING & PACKER	Sherwood Medical Co.	1995-08-23	58
K951166	BIODERM MEDICAL HYDROGEL ISLAND DRESSING	Bioderm, Inc.	1995-06-21	99
K950412	CURAGEL HYDROGEL WOUND DRESSING	Kendall Healthcare Products Co. Div.Of Tyco Health	1995-03-24	52
K945832	BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BOR	Brady Medical Products Co.	1995-03-01	92
K942748	INTRASITE	Smith & Nephew United, Inc.	1994-06-29	19
K941019	BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING	Brady Medical Products Co.	1994-05-04	62
K935705	ALLEVYN ISLAND WOUND DRESSING	Smith & Nephew United, Inc.	1994-02-15	77
K934601	NDM HYDROGAUZE WOUND DRESSING	Ndm Acquisition Corp.	1994-02-15	144
K935848	BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING	Brady Medical Products Co.	1994-02-15	69
K932336	NU-GEL ISLAND WOUND DRESSING	Johnson & Johnson Medical, Inc.	1994-02-09	271
K931618	DUODERM HYDROCOLLOID GEL	Convatec, A Division of E.R. Squibb & Sons	1993-12-10	252
K926508	INTRASITE GEL	Smith & Nephew United, Inc.	1993-07-13	195
K926202	CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI	Ndm Corp.	1993-05-12	154
K922666	TRANSORB(TM) ULCER & WOUND DRESSING	Brady Medical Products Co.	1992-11-23	179
K915359	PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH	Medtronic Vascular	1992-05-28	183
K915357	PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH	Medtronic Vascular	1992-05-28	183
K915182	DEROYAL HYDROGEL DRESSING	Deroyal Industries, Inc.	1992-04-21	158
K920677	CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION	New Dimensions IN Medicine, Inc.	1992-04-21	67
K914207	CLEARSITE(R) STERILE WOUND CARE DRESSING	Ndm Acquisition Corp.	1991-10-23	34
K810902	IP-758 BURN WOUND DRESSING	Exopack	1981-09-11	161
K802793	LOMATUELL OINTMENT DRESSING	Secol Co.	1980-12-18	44

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