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

MGQ — Predicate Candidate Screening

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

85 daysmedian FDA review time

221 days90th percentile

145clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171879	HylaGuard Moisturizing Cream	Founders Science Group, LLC	2017-10-16	115	0
K083024	HYLATOPIC EMOLLIENT FOAM	Collegium Pharmaceutical Incorporated	2009-03-27	169	0
K041342	IMPRUV A.I. CREAM WOUND AND SKIN EMULSION	Stiefel Laboratories, Inc.	2005-07-19	425	0
K041268	SILVERSITE OR CALGITROL	Adri	2004-09-20	131	0
K040019	SILVERSEAL	Noble Fiber Technologies	2004-07-23	199	0
K040517	TENDERWET ACTIVE	Medline Industries, Inc.	2004-03-25	27	0
K022587	MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS	Medtrade Products , Ltd.	2003-08-22	382	0
K024367	SINCLAIR WOUND AND SKIN EMULSION	Sinclair Pharmaceuticals, Ltd.	2003-07-28	209	0
K024054	XYLOS XCELL ANTIMICROBIAL DRESSING	Xylos Corporation	2003-03-07	88	0
K022584	CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING	Cardiotech Intl.	2002-12-30	147	0
K022995	COLLATEK HYDROGEL	Biocore Medical Technologies, Inc.	2002-12-02	84	0
K013525	CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610	Coloplast Corp.	2002-10-04	346	0
K020325	L.A.M. IPM WOUND GEL	L.A.M. Pharmaceutical, Corp.	2002-04-15	74	0
K011994	ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101	Acrymed, Inc.	2001-11-08	135	0
K010583	AMBU GEL, HYDROGEL BURN DRESSING	Ambu, Inc.	2001-05-25	87	0
K002666	DIAMOND ALOE VERA, STERILE	Medi-Tech Intl. Corp.	2001-02-27	186	0
K003396	BURN JEL PLUS	Water-Jel Technologies, LLC	2001-01-11	71	0
K002078	BETA GLUCAN GEL (MACROPRO GEL)	Brennen Medical, Inc.	2000-10-02	84	0
K002077	GLUCANPRO CREAM	Brennen Medical, Inc.	2000-10-02	84	0
K002129	FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN	Ferris Mfg. Corp.	2000-08-25	42	0
K000519	GLUCANPRO	Brennen Medical, Inc.	2000-05-01	75	0
K000518	MACROPRO GEL	Brennen Medical, Inc.	2000-05-01	75	0
K991755	MEDLINE TENDER WET WOUND DRESSING	Medline Industries, Inc.	2000-04-17	329	0
K992074	MPM REGENECARE WOUND GEL	Mpm Medical., Inc.	1999-12-23	188	0
K993119	STERILE HYDROGEL	Dumex Medical Surgical Products, Ltd.	1999-11-23	64	0
K990179	BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD	Nortrade Medical, Inc.	1999-08-13	205	1
K990178	BURNFREE PAIN RELIEVING GEL, MODEL 4B	Nortrade Medical, Inc.	1999-08-13	205	0
K990180	BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING	Nortrade Medical, Inc.	1999-08-13	205	0
K990440	GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE	Gentell	1999-08-12	182	0
K991202	MODIFICATION TO WOUN'DRES	Coloplast Corp.	1999-06-04	74	0
K990368	DUODERM HYDROACTIVE GEL WOUND DRESSING	Convatec, A Bristol-Myers Squibb Co.	1999-03-26	46	0
K984370	HYPERGEL 20% HYPERTONIC SALINE GEL	Molnlycke Health Care, Inc.	1999-03-01	84	0
K984368	NORMLGEL 0.9% ISOTONIC SALINE GEL	Molnlycke Health Care, Inc.	1999-02-22	77	0
K984267	MODIFICATION OF BIONECT HYDROGEL FOAM	Fidia Pharmaceutical Corp.	1999-02-10	85	0
K984413	BIONECT HYDROGEL	Fidia Pharmaceutical Corp.	1999-02-10	85	0
K984262	MODIFICATION OF BIONECT HYDROGEL GAUZE PADS	Fidia Pharmaceutical Corp.	1999-02-10	85	0
K984266	MODIFICATION OF BIONECT HYDROGEL SPRAY	Fidia Pharmaceutical Corp.	1999-02-10	85	0
K984264	MODIFICATION OF BIONECT CLEAR HYDROGEL	Fidia Pharmaceutical Corp.	1999-02-10	85	0
K984082	BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLA	Emox 911 CC	1999-01-28	73	0
K983362	NU-GEL * WOUND DRESSING	Johnson & Johnson Medical, Inc.	1998-12-16	83	0
K982804	SPYROGEL HYDROGEL WOUND AND BURN DRESSING	Innovative Technologies (Us), Inc.	1998-12-16	128	0
K983042	SWEEN WOUN'DRES	Coloplast Corp.	1998-11-25	86	0
K982825	BRENNEN MEDICAL BETA GLUCAN GEL	Brennen Medical, Inc.	1998-11-06	87	0
K982577	NEUFINISH RESURFACING CREAM	Neutrogena Corp.	1998-10-21	89	0
K982306	POLYTUBE	Ferris Mfg. Corp.	1998-09-22	83	0
K973724	BIONECT HYDROGEL SPRAY	Fidia Pharmaceutical Corp.	1998-09-22	357	0
K973722	BIONECT HYDROGEL FOAM	Fidia Pharmaceutical Corp.	1998-09-22	357	0
K973725	BIONECT CLEAR HYDROGEL	Fidia Pharmaceutical Corp.	1998-09-22	357	0
K973721	BIONECT HYDROGEL GAUZE PADS	Fidia Pharmaceutical Corp.	1998-09-22	357	0
K980962	BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO	Brennen Medical, Inc.	1998-07-29	135	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