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

LGF — Predicate Candidate Screening

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

28 daysmedian FDA review time

126 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K043526	SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC	Noble Fiber Technologies, Inc.	2005-03-10	79
K973420	CLINITEX CAST PADDING	Clinitex Medical Corp.	1997-12-09	90
K973417	CLINITEX STOCKINETTE	Clinitex Medical Corp.	1997-12-09	90
K955320	PROTEC COTTON PADDING BANDAGE	Derivadas Degasa S.A. DE C.V.	1996-01-26	67
K932507	QUICK-CAST IMMOBILIZER	Landec Corp.	1994-02-23	274
K931672	CARAPACE STERILE CAST PADDING	Carapace, Inc.	1993-12-15	253
K910274	ARTIFLEX(TM)	Beiersdorf, Inc.	1991-03-05	41
K903946	COOL CAST(R)	Hawthorne Products, Inc.	1990-12-31	126
K896634	CARAGLAS XTRA SYNTHETIC CASTING TAPE	Buckman Co., Inc.	1990-06-14	204
K883294	SYNTHETIC CAST TAPE	Carapace, Inc.	1988-08-30	26
K874880	COLORED CASTING TAPE CARAGLAS(TM GREEN	Synthetic Mfg., Inc.	1987-12-30	29
K873722	PEDESTAL WALKING HEEL PRODUCT NO. 4183-133	Martin Medical	1987-10-02	17
K873718	CHILD WALKING HEEL PRODUCT NO. 4183-132	Martin Medical	1987-10-02	17
K873717	CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135	Martin Medical	1987-10-02	17
K870404	COLORED CASTING TAPE (RED AND BLUE)	Buckman Co., Inc.	1987-02-13	10
K864092	OEC DESIGN ORTHOPEDIC CAST HEEL	Military Engineering, Inc.	1986-12-16	56
K861075	AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202	Martin Medical	1986-03-28	7
K861073	AMERICAN ORTHOPAEDIC VACUUM 0295-250	Martin Medical	1986-03-28	7
K861074	AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200	Martin Medical	1986-03-28	7
K854554	DELTA-LITE CASTING RESIN	Johnson & Johnson Professionals, Inc.	1985-12-11	28
K854341	DELTA-LITE CASTING RESIN	Johnson & Johnson Professionals, Inc.	1985-11-22	25
K843780	VENT-A-CAST	Orthopedic Technology, Inc.	1984-11-14	49
K840617	MASTERFOOT CAST HEEL	Seton Products, Inc.	1984-03-23	39
K833084	MASTERHINGE	Mark One Healthcare Products	1983-10-14	31
K823819	CAST TOE COVER	Danek Medical, Inc.	1983-01-14	28
K823394	WALKING HEEL	Orthopedic Systems, Inc.	1982-12-03	21
K822059	SHOW'RBAG	The Healthcare Group Laboratories, Inc.	1982-07-22	9
K812904	STERILE ORTHOPEDIC STOCKINETTE	Alba Health Care	1982-01-18	91
K810110	COBBLER'S CHIP SPLINTS	Secol Co.	1981-01-26	10
K803141	CONPHAR CAST HEELS	Conphar, Inc.	1981-01-09	28
K780283	INSERTER, PLUG, BONE, LIDGE	Depuy, Inc.	1978-03-17	24

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