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

NAB — Predicate Candidate Screening

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

61 daysmedian FDA review time

128 days90th percentile

88clearances measured

K-number	Device	Applicant	Decided	Review days
K946015	IVALON EXTERNAL SPONGE	Ivalon	1995-02-27	80
K940755	ISOLYER (4X4, 8PLY)	Isolyer Co.	1994-05-02	73
K931610	OMNISORB II, NONWOVEN SPONGE, STERILE AND NON	Omni Mfg., Inc.	1993-06-24	84
K925590	MULTI-TRAUMA DRESSING	Gam Industries, Inc.	1993-04-08	154
K926072	K-BAND AND K-CREPE	Parema , Ltd.	1993-03-19	108
K915591	STERILE GAUZE PADS	Eagle Medical, Inc.	1993-01-27	411
K924650	GAUZE SPONGES	Dav-Mar Medical Products, Inc.	1993-01-11	118
K923602	ABSORBENT PAD -- MODIFICATION	Winfield Laboratories, Inc.	1992-12-07	145
K923115	CLINISORB	Hermitage Hospital Products, Inc.	1992-11-23	151
K923116	COMBINE II WETPROOF PAD	Hermitage Hospital Products, Inc.	1992-10-06	103
K923378	USP TYPE VII GAUZE SPONGES	E.W.A., Ltd.	1992-10-06	89
K923846	BURN DRESSING	Medical Action Industries, Inc.	1992-09-11	42
K921227	TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE	Courtaulds Fibers, Inc.	1992-05-29	77
K920282	PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE	Trinity Laboratories, Inc.	1992-05-29	128
K915821	MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES	Kerma Medical Products, Inc.	1992-05-29	151
K920269	EZ GAUZE SPONGE	Cal West Trading Co.	1992-04-22	92
K915822	MULTIPLE DRESSING, STERILE NONADDHERENT PADS	Kerma Medical Products, Inc.	1992-03-26	87
K914604	MEPITEL NON-ADHERENT SILICONE DRESSING	Molnlycke Clinical Products AB	1992-03-25	160
K913779	BANDAGE ROLL, GAUZE	Keilei Intl., Inc.	1991-12-04	112
K914071	MULTIPLE BURN DRESSING	Kerma Medical Products, Inc.	1991-12-04	84
K914842	GAUZE BANDAGE ROLL	Cal West Trading Co.	1991-12-04	37
K914937	STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES	Kerma Medical Products, Inc.	1991-12-04	30
K914431	ABSORBENT FIBER	Ulti-Med Intl., Inc.	1991-12-04	61
K912952	BANDAGE COMPRESS	Cal West Trading Co.	1991-10-04	94
K912692	CONFORMING BANDAGE	Ulti-Med Intl., Inc.	1991-10-04	108
K912693	POST OPERATIVE SPONGE	Ulti-Med Intl., Inc.	1991-10-04	108
K912950	COMPRESS DRESSING	Cal West Trading Co.	1991-10-04	94
K912953	GAUZE COMPRESS	Cal West Trading Co.	1991-09-30	90
K912779	GAUZE SPONGE,STERILE 2'S	Keilei Intl., Inc.	1991-09-30	98
K912954	STRETCH GAUZE BANDAGE	Cal West Trading Co.	1991-09-10	70
K912951	12-PLY GAUZE PAD	Cal West Trading Co.	1991-09-10	70
K912949	TRIANGULAR BANDAGE,40	Cal West Trading Co.	1991-09-06	61
K910857	ALLDRESS MULTI LAYERED WOUND DRESSING	Scott Health Care	1991-04-12	43
K895727	BACKGROUND SUCTION MATT	Applied Medical Technologies, Inc.	1989-10-24	29
K891324	HERMITEX SPONGE	Hermitage Hospital Products, Inc.	1989-04-27	45
K891101	NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING	Smith & Nephew United, Inc.	1989-04-17	46
K890672	ABSORBENT GAUZE ROLL	Smith & Nephew United, Inc.	1989-04-07	57
K884334	GAUZE BANDAGE 1 X 6 YDS.	North Health Care	1989-01-09	87
K884333	GAUZE BANDAGE 2 X 6 YDS.	North Health Care	1989-01-09	87
K884335	GAUZE BANDAGE 4 X 6 YDS.	North Health Care	1989-01-09	87
K882115	A-SORB	Howard Medical Co.	1988-10-03	137
K870283	3 X 3 SPONGES, NON-STERILE	The Medical Group, Inc.	1987-02-24	28
K870282	4 X 4 SPONGES, NON-STERILE	The Medical Group, Inc.	1987-02-24	28
K864264	TRICOTEX WOUND CONTACT LAYER DRESSING	Smith & Nephew, Inc.	1986-12-29	61
K833735	AN ODOR ABSORBENT BANDAGE	American Medical Disposable, Inc.	1984-04-23	181
K833549	PDI SURGICAL SCRUB/BRUSH T150-70	Nice-Pak Products, Inc.	1983-11-28	88
K831886	FEMORAL CANAL SPONGE	Zimmer, Inc.	1983-09-12	91
K831284	GAUZE BANDAGE	Pac-Kit Safety Equipment Co.	1983-08-12	112
K831282	BANDAGE COMPRESS	Pac-Kit Safety Equipment Co.	1983-08-12	112
K831281	GAUZE COMPRESS	Pac-Kit Safety Equipment Co.	1983-08-12	112

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