Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

KDC · Predicate Candidate Screening

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

57 daysmedian FDA review time

147 days90th percentile

67clearances measured

K-number	Device	Applicant	Decided	Review days
K943229	DISPOSABLE SURGICAL SCISSORS AND FORCEPS	Y.M.K. International Co., Ltd.	1994-08-19	44
K936226	SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET	Meadox Medicals, Div. Boston Scientific Corp.	1994-03-07	68
K920153	THERMUFF BAG	Techstyles	1992-07-01	170
K920263	MANUAL SURGICAL INSTRUMENTS	Phoenix Instruments Div.	1992-05-06	106
K915064	DISPOSABLE CAUTERY ABRASIVE PAD	American Medical Mfg., Inc.	1992-03-11	124
K914960	INSTRUMENT ORGANIZER	O.R. Concepts, Inc.	1992-02-28	115
K912834	SHUR-GRIP	Inman Medical Corp.	1991-07-26	30
K910079	DISPOSABLE INTRODUCER SHEATH	Applied Vascular Devices, Inc.	1991-02-27	50
K905240	VESSELOOPS	Sparta Surgical Corp.	1991-02-06	78
K903649	BRADLEY TENACULUM HOLDER	Marlo Surgical Technology	1990-11-02	81
K900566	RICHARD-ALLAN VESSEL LOOPS	Richard-Allan Medical Ind., Inc.	1990-05-03	85
K896676	KEY VASCULAR LOOPS	Key Surgical, Inc.	1990-02-27	92
K854890	HOOK PROBE	Euro-Med Intl.	1986-05-02	147
K854894	SPOON	Euro-Med Intl.	1986-05-02	147
K854895	BASKET FORCEP	Euro-Med Intl.	1986-05-02	147
K854896	HOOK SCISSOR	Euro-Med Intl.	1986-05-02	147
K854897	MAX-I-GRASP	Euro-Med Intl.	1986-05-02	147
K854898	ATLANTIC GRASPER	Euro-Med Intl.	1986-05-02	147
K854901	PACIFIC GRASPER	Euro-Med Intl.	1986-05-02	147
K853597	INSTRUMENT MAKAR DISPOSALBE LOOP	Instrument Makar, Inc.	1985-09-23	27
K832441	SUTURE-AID BOOTIES	Omega-Med Intl., Inc.	1984-03-05	224
K833355	SDC VASCULAR TIES	Science Development Corp.	1984-01-27	121
K831118	PMT-OPTICA LINE	Pmt, Inc.	1984-01-25	295
K832680	MICRO-EDGE DISPOSABLE BLADES	Micromedics, Inc.	1983-10-14	66
K830800	C-LOOPS	Concept, Inc.	1983-10-04	204
K831842	DRAVON T CLAMP	Dravon Medical, Inc.	1983-09-26	110
K831664	PLASTIC THUMB FORCEPS	Medcare Products	1983-09-12	112
K831665	DISPOSABLE NEEDLE HOLDER	Medcare Products	1983-09-12	112
K831911	DISPOSABLE FLOOR INSTRUMENTS	Ormed Mfg., Inc.	1983-09-12	90
K831915	SAFETY PINS & RUBBER BANDS	Ormed Mfg., Inc.	1983-09-12	90
K831661	DISPOSABLE SCISSORS	Medcare Products	1983-08-25	94
K831662	DISPOSABLE HEMOSTAT (STRAIGHT&CURVED	Medcare Products	1983-07-19	57
K831798	DISPOSABLE SCALPELS	I M, Inc.	1983-07-19	46
K830248	DEVO'N LOOPS	Devon Industries, Inc.	1983-03-08	42
K830326	NEGATIVE PRESSURE ARTERIAL BLOOD LINE	Erika, Inc.	1983-02-28	27
K822065	KAM SUCKER	The Anspach Effort, Inc.	1982-08-16	33
K821166	KOLOR KODE TM	Devon Industries, Inc.	1982-05-13	17
K820638	PEDIATRIC SUCKER	3M Health Care, Sarns	1982-04-09	32
K820161	AXIOM LIG-A-BOOTS	Axiom Medical, Inc.	1982-03-15	54
K820158	OLSEN #770 DISPOSABLE HOLSTER	Olsen Electro-Surgical Instruments, Inc.	1982-02-05	16
K811712	TIP WIPE	Devon Industries, Inc.	1981-07-20	33
K811822	TIP-VU	Instranetics, Inc.	1981-07-20	21
K811823	SHARPS CADDY FB	Instranetics, Inc.	1981-07-20	21
K811824	CAUTERY CADDY PAD	Instranetics, Inc.	1981-07-20	21
K811303	ALTRACLUDE	R&H Medical, Inc.	1981-06-16	36
K811280	FLEX-TEMPLATE	Mick Radio-Nuclear Instruments, Inc.	1981-06-02	25
K811191	DAVIS & GECK NEEDLE/SHARPS COUNTER	Davis & Geck, Inc.	1981-05-27	27
K811120	SURGICAL STAPLE REMOVER	Acme United Corp.	1981-05-05	11
K810883	OMED SILICONE INSTRUMENT COVERS	Omega-Med Intl., Inc.	1981-04-23	22
K810785	SKIN STAPLE REMOVER	Rowley Mfg. Co.	1981-04-10	18

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