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

ITG — Predicate Candidate Screening

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

35 daysmedian FDA review time

92 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K873111	CONFORMA(TM) PLASTER BANDAGES	The Kendal Co.	1987-10-09	60
K862115	DEKNA BAND KIT	Deknatel, Inc.	1986-08-19	77
K842573	T.P.G. CAST TAPE	The Poly Group, Inc.	1984-08-10	38
K840416	HEXCELITE	Hexcel Medical	1984-03-23	52
K833732	NON WETTING UNDERCAST PADDING	American Medical Disposable, Inc.	1983-12-12	48
K832992	SOFFBAN ORTHOPEDIC PADDING	Smith & Nephew, Inc.	1983-11-14	73
K832237	ORTHOPEDIC CASTING TAPE MAXCAST	Cutter Laboratories, Inc.	1983-08-16	36
K830650	SUPPORT PRODUCTS EXAMPLE PROSET CAST	Isopedix Corp.	1983-07-07	126
K831492	YESONA PLASTER OF PARIS BANDAGE	Watson Phillips Y Cia. Sucs., S.A. DE C.V.	1983-06-30	51
K820890	URETHANE ORTHOPAEDIC CASTING TAPE	Hexcel Medical	1982-06-23	85
K820140	WEBRIL CAST PADDING	Stan-Pak Ent.	1982-02-12	24
K820155	SPECIALIST CAST PADDING	Stan-Pak Ent.	1982-02-12	24
K813052	ULTRACAST WATERLESS SYNTHETIC RESIN CAST	Zimmer, Inc.	1982-02-04	98
K813219	CARAFLEX ELASTIC POLYMER PLASTER BANDA	Carapace, Inc.	1981-12-17	38
K811754	CRYSTONA	Smith & Nephew, Inc.	1981-07-20	28
K811164	URETHANE ORTHOPAEDIC CASTING TAPE	Hexcel Medical	1981-05-27	29
K810877	ORTHOSIS BANDAGES	Ortho-Cast, Inc.	1981-04-17	17
K810111	CELLONA PLASTER VARNISH	Secol Co.	1981-02-04	19
K802792	CELLONA	Secol Co.	1980-12-10	36
K802796	CELLAMIN	Secol Co.	1980-11-24	20
K800749	IPOCON 7	Ipos Luneburg	1980-07-28	115
K800695	BVN	Donald J. Mangus, M.D.	1980-05-02	35
K800752	PRE-PADDED PLASTER/PARIS BAND/SPLINTS	Ortho-Care, Inc.	1980-04-21	17
K800195	COTTON UNDER CAST PADDING	Winn Hirsch & Assoc.	1980-02-11	13
K791831	PROCAST	Medical Specialties, Inc.	1979-09-24	6
K791305	FELTLOC CAST PADDING	Howmedica Corp.	1979-07-30	14
K791094	3M ORTHOPEDIC CASTING TAPE	3M Company	1979-07-24	42
K790320	DELTA-LITE	Johnson & Johnson Professionals, Inc.	1979-05-18	92
K771452	CONFORM STRETCH BANDAGE (5SIZES)	Kendall Research Center	1977-09-12	40
K770929	BANDAGES, SPEC. X-TRA HARD OR PLASTER	Johnson & Johnson Professionals, Inc.	1977-06-02	10
K770742	CUTTER CAST 7	Cutter Laboratories, Inc.	1977-04-28	6
K770340	BANDAGES, PLASTER OF PARIS & SPLINTS	Johnson & Johnson Professionals, Inc.	1977-02-28	10
K770134	LIGHTCAST II STOCKINETTE	Solar Laboratories, Inc.	1977-01-26	5
K770133	LIGHTCAST II CASTING SYSTEM (MODIFIED)	Solar Laboratories, Inc.	1977-01-26	5
K760841	HEXCELITE SHEET SPLINTS	Hexcel Medical	1976-11-01	19
K760413	TAPE, LIGHTCAST II WB	Solar Laboratories, Inc.	1976-08-23	14
K760003	CAST MATERIAL (WICKET STOCKINETTE)	Zimmer, Inc.	1976-07-26	61

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