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

KDD — Predicate Candidate Screening

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

60 daysmedian FDA review time

221 days90th percentile

62clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K072814	CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND	Covidien	2008-04-16	198	0
K011514	INSTRUMENTS FOR ONE TIME USE - DISPOSABLE	Kencap , Ltd.	2001-08-13	88	0
K971317	NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS	National Healthcare Mfg. Corp.	1997-05-08	29	0
K960456	DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEED	Denver Biomaterials, Inc.	1996-04-01	62	0
K936255	CUSTOM CV PACK	Associated Medical	1994-03-31	91	0
K932219	SUTURE SET OR LACERATION TRAYS (PACKS)	Associated Medical Products Co.	1993-07-09	63	0
K923176	SURGICAL INSTRUMENT KIT, DISPOSABLE	Ulti-Med Intl., Inc.	1993-06-17	370	0
K925905	KIT, SURGICAL INSTRUMENT, DISPOSABLE	Kay Medical Concepts	1993-06-16	210	0
K924958	BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY	Medical Insights, Inc.	1993-06-07	250	0
K925215	STERILE SURGICAL INSTRUMENT TRAYS	American Healthcare Supply Co., Inc.	1993-06-01	228	0
K924117	DEXIDE LAPAROSCOPIC KITS	Dexide, Inc.	1993-03-23	221	0
K920989	SURGICAL INSTRUMENT KIT, DISPOSABLE	Ulti-Med Intl., Inc.	1992-10-19	231	0
K920763	LACERATTION TRAY	Sterile Concepts, Inc.	1992-09-28	222	0
K920516	GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB	Trinity Laboratories, Inc.	1992-04-16	72	0
K914244	STERILE CUSTOM SURGICAL KITS	Ulti-Med Intl., Inc.	1992-02-24	154	0
K913049	SLIP-PRUF-CLINGER	Macbrud Corp. Medical Div.	1991-09-11	64	0
K911606	BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES	Baxter Healthcare Corp	1991-07-09	90	0
K910816	IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE	Insight International, Inc.	1991-04-17	50	0
K910366	MEGA GENERAL PURPOSE INSTRUMENT KIT	Megadyne Medical Products, Inc.	1991-03-28	58	0
K910369	INCISION AND DRAINAGE KIT	Megadyne Medical Products, Inc.	1991-03-28	58	0
K902441	DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)	Currie Medical Specialties, Inc.	1990-08-23	83	0
K880785	SKILCRAFT	Pennsylvania Association For the Blind	1988-03-11	14	0
K874063	ENTERON ABDOMINAL PARACENTESIS TRAY	Endovations	1987-12-04	60	1
K871458	SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW	Fraass Survival Systems, Inc.	1987-07-09	87	0
K870373	STERILE PROCEDURAL TRAYS	Dimed, Intl.	1987-03-20	50	0
K864969	JMS HALO APPLICATION TRAY	Jerome Medical	1987-02-18	58	0
K853910	SUTURE REMOVAL KIT	Scientific & Medical Care Co.	1985-10-08	18	0
K843206	COOK COUNTY HOSPITAL DRESSING CHANGE SET	Geneva Laboratories, Inc.	1985-05-24	282	0
K850325	STERILE SUTURE REMOVAL KIT	Excel Health Care Products	1985-02-26	29	0
K842627	C-SECTION TRAY	Deroyal Industries, Inc.	1984-09-26	82	0
K843115	STERILE SOLUTION BOWL	E.M. Adams	1984-09-07	30	0
K834135	STERILE SUTURE BOOTS	Devon Industries, Inc.	1984-04-27	148	0
K833438	PREPACELL-STERILE-BONE MARROW ASPIR	Applied Medical Devices, Inc.	1984-02-09	127	0
K832628	VYGON THORACIC DRAINAGE-VARIOUS #'S	Exco, Inc.	1984-01-30	179	0
K833075	WET DRESSING KIT	Clinipad Corp.	1984-01-27	140	0
K834532	STERILE WET DRESSING PACK	W.G. Whitney Corp.	1984-01-25	35	0
K831841	STERILE DISP. INSTRUMENT TRAYS	E.M. Adams	1983-12-14	190	0
K832047	STERILE SUTURE REMOVAL SET	Ormed Mfg., Inc.	1983-09-12	80	0
K831795	FIRST AID KITS	I M, Inc.	1983-09-01	90	0
K830374	RESCUE PACK	Akla, Inc.	1983-05-13	98	0
K822158	OPEN HEART TRAY (CUSTOM DESIGNED)	Megaplast, Inc.	1982-10-13	82	0
K821814	HEMO-NATE L-P KIT	Int'L Corp.	1982-07-09	21	1
K821502	STERILE SUTURE REMOVAL KIT	Pro-Pak	1982-07-09	51	0
K821500	STERILE CATH CARE KIT	Pro-Pak	1982-06-23	35	0
K821501	STERILE TRACHEOSTOMY CARE KIT	Pro-Pak	1982-06-16	28	0
K820423	SUTURE REMOVAL TRAY	Megaplast, Inc.	1982-03-10	22	0
K813103	ACKRAD INCISION & DRAIN SET	Ackrad Laboratories	1981-12-09	36	0
K811855	SKIN SCRUB KITS	Oem Medical Div.	1981-07-31	30	0
K811086	SUTURE REMOVAL SET(DISPLSABLE)	Cunningham Woodland, Inc.	1981-05-01	10	0
K803199	SUTURE REMOVAL KIT	Walpak Co.	1981-01-15	29	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