Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EFQ — Predicate Candidate Screening

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

39 daysmedian FDA review time

122 days90th percentile

271clearances measured

K-number	Device	Applicant	Decided	Review days
K991757	NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERI	Furlong Industries	1999-08-12	80
K991215	SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S	Symtex Healthcare Corp.	1999-06-11	63
K990974	VITOP DRESSING	Wonder & Bioenergy Hi-Tech America, Inc.	1999-06-09	78
K990584	GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE	Broadline Medical Industries	1999-04-23	59
K984187	CROSSTEX NON-WOVEN SPONGES	Crosstex Intl.	1999-02-18	87
K983016	GAUZE, SPONGES, CAT # 11-003	Vitalcare Group, Inc.	1999-02-12	168
K983348	DYNAREX TRACHEOSTOMY SPONGE	Dynarex Corp.	1998-12-11	79
K983450	STARRYSHINE GAUZE SPONGE	T.C. Dental Products, Inc.	1998-11-12	43
K982648	JOAN II	Celanese Acetate Co.	1998-09-30	63
K980791	DUMEX PAK-ITS WOVEN RIBBON PACKING	Dumex Medical Surgical Products, Ltd.	1998-04-29	58
K974316	HYDROFERA FEMORAL WICK	Hydrofera, LLC	1998-02-13	88
K974347	BALDUR NON-STERILE COTTON SPONGES	Baldur Systems Corp.	1998-02-10	83
K973763	KENDALL CURITY IODOFORM PACKING STRIP	Kendall Healthcare Products Co. Div.Of Tyco Health	1997-12-31	90
K973580	INVOTEC CLEAN PAD	Invotec International, Inc.	1997-12-10	82
K973299	PIN CARE KIT	Brown Medical Industries	1997-11-26	85
K971095	OPPORTUNITY SUTURE REMOVAL KIT	Opportunity, Inc.	1997-09-16	176
K971088	OPPORTUNITY INCISION AND DRAINAGE TRAY	Opportunity, Inc.	1997-09-16	176
K971178	RAND SURGICAL SPONGE	Trans Aire	1997-06-27	88
K971075	PRIMED PRIME-PLUS COTTON GAUZE SPONGES	Primeline Medical Products, Inc.	1997-06-22	90
K970457	DUKAL ABD COMBINE PAD	Dukal Corp.	1997-05-08	91
K970455	DUKAL NON ADHERENT DRESSING	Dukal Corp.	1997-05-08	91
K970020	SIMAR, INC. SURGICAL DRESSING	Simar, Inc.	1997-03-20	76
K963724	GAUZE SPONGE, NON X-RAY DETECTABLE	Grand Medical Products	1996-11-29	74
K960615	GAUZE COMPRESS	Certified Safety Mfg., Inc.	1996-11-25	286
K963188	DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)	Codi International BV	1996-10-30	76
K962972	SURGICADE GAUZE SPONGE	Accunex Canada,Inc.	1996-10-11	72
K963134	DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)	Igenics, Inc.	1996-09-06	25
K962227	PRO-FECT STERILE GAUZE SPONGES	Network Trading Corp. Dba Grand Intl.	1996-08-19	70
K961773	PROTEC STERILE GAUZE SPONGE	Derivadas Degasa S.A. DE C.V.	1996-07-29	82
K961775	PROFORE FOUR-LAYER BANDAGE SYSTEM KIT	Smith & Nephew United, Inc.	1996-07-16	69
K962234	STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16P	Howard Medical Co.	1996-06-28	17
K961061	CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)	Codi International BV	1996-06-06	80
K961581	EMERALD STERILE GAUZE SPONGE	Emerald Medical, Inc.	1996-05-28	34
K960523	NHMC DRESSING TRAY	National Healthcare Mfg. Corp.	1996-04-04	58
K960388	DYNAREX NON-WOVEN SPONGE	Dynarex Corp.	1996-04-01	66
K960093	PROTEC ROLL GAUZE	Derivadas Degasa S.A. DE C.V.	1996-03-25	74
K955527	GENERAL USE SYNTHETIC SPONGE (STERILE)	Igenics, Inc.	1996-02-05	63
K955165	SYNTHETIC SPONGE	Igenics, Inc.	1996-02-05	84
K955321	PROTEC GAUZE SPONGE	Derivados DE Gasa, S.A. DE C.V.	1995-12-19	29
K953914	KENTEX	Kentron Health Care, Inc.	1995-11-06	77
K953810	FLUFF GAUZE BANDAGE, STERILE & NON-STERILE	K. W. Griffen Co.	1995-09-14	37
K953072	MEROCEL VAGINAL PACK	Merocel Corp.	1995-09-12	74
K953501	ADI STERILE GAUZE SPONGES	Asia Dynamics, Inc.	1995-08-28	33
K950906	LESINSKI SURGICAL EAR DRESSING	Microtek Medical, Inc.	1995-06-22	114
K950258	HEMO-BARRIER TOURNIQUET	Hemo-Barrier Technologies, Inc.	1995-06-19	147
K951660	DYNAREX GAUZE SPONGE	Dynarex Corp.	1995-05-09	29
K950404	LOCKETT MEDICAL CORP. GAUZE	Lockett Medical Corp.	1995-04-17	76
K950462	GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)	Spring Intl., Inc.	1995-04-14	70
K951418	LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2	Lorons International Corp.	1995-04-14	17
K945002	1X6YD, 2X6YD, 4X6YD ROLL BANDAGE	Certified Safety Mfg., Inc.	1995-03-22	160

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