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

GEC — Predicate Candidate Screening

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

29 daysmedian FDA review time

65 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K971473	IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK	M-Pact Worldwide Management Corp.	1997-07-07	75
K960621	EXPANDACELL INSTRUMENT WIPE	Shippert Medical Technologies Corp.	1996-04-01	48
K900691	BIODYNE INSTRUMENT WIPES	Bio-Dyne, Inc.	1990-03-08	23
K896085	SURGI-BRUSH	Sparta Surgical Corp.	1989-11-08	20
K875033	STERILE SCRUBBY SCRUB BRUSH	Medsurg Industries, Inc.	1988-02-19	74
K875129	STERI-CLENS	Absorbent Cotton Co., Inc.	1988-02-18	65
K872823	DELTA SCRUB	Pacific Biosystems, Inc.	1988-01-07	175
K874653	STERILE SURGICAL SCRUB BRUSH	Surgikos, Inc.	1987-12-30	47
K874741	STERI-CLENS(TM) SURGICAL SCRUB SPONGE	Absorbent Cotton Co., Inc.	1987-12-10	17
K870258	BIOSCRUB SURGICAL SCRUB BRUSH	K. W. Griffen Co.	1987-02-24	32
K854232	PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES	American Pharmaseal Div. Ahsc	1985-12-10	50
K844411	SCRUB MATE DRY STERILE SCRUB BRUSH	American Sterilizer Co.	1984-12-17	33
K843636	FOAM CARE ONE STEP PREP	Ballard Medical Products	1984-11-16	60
K831488	DAVRON PROF. SCRUB BRUSH-DRY/STERILE	Minnetonka, Inc.	1983-06-08	29
K831226	MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450	Ballard Medical Products	1983-05-16	31
K830394	PROVIDONE-IODINE PREP-PADS & TOWELETTES	H & P Industries, Inc.	1983-04-06	58
K830393	PROVIDONE-IODINE SWABSTICKS	H & P Industries, Inc.	1983-04-06	58
K823173	ARRIRM SCRUB BRUSH/SPONGE	The Buckeye Cellulose Corp.	1982-11-22	27
K823061	BRUSH, SCRUB, OPERATING ROOM	Seamless Hospital Products Co.	1982-11-05	18
K822865	SURGI-SCRUB V	Acme United Corp.	1982-10-18	21
K821497	DISPOSABLE SURGICAL SCRUB BRUSHES	Medical Systems Research	1982-07-14	56
K820086	CURITY SURGICAL SCRUB BRUSH SPONGE	The Kendal Co.	1982-01-28	16
K810655	DISPOSABLE SCRUB BRUSH	Dexide, Inc.	1981-05-05	63
K810337	PDI SURGICAL SCRUB SPONGE-BRUSH-T15070	Nice-Pak Products, Inc.	1981-02-26	17
K803116	HEAVY DRAINAGE PACK	American Medical Disposable, Inc.	1981-01-28	49
K800058	ANAGO ELECTRO SURGICAL TIP CLEANER	Anago, Inc.	1980-01-28	18
K792272	DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO	Dexide, Inc.	1979-12-27	44
K792273	DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P	Dexide, Inc.	1979-12-10	27
K792242	SURGI-PREP PAINT STICK #1 WET PACK	Gard Research Corp.	1979-12-10	33
K792271	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Dexide, Inc.	1979-12-10	27
K791949	DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH	Dexide, Inc.	1979-10-17	16
K791951	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Dexide, Inc.	1979-10-17	16
K791952	DEXIDE DISPOSABLE SURGICAL SCRUB BRUSH	Dexide, Inc.	1979-10-17	16
K791950	DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE	Dexide, Inc.	1979-10-17	16
K791736	MEROCEL INSTRUMENT WIPE	Xomed, Inc.	1979-09-19	19
K782173	SURGERY BRUSH	Dexide, Inc.	1979-01-10	12
K782172	BRUSH/SPONGE, DISPOSABLE	Dexide, Inc.	1979-01-10	12

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