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

FPX — Predicate Candidate Screening

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

54 daysmedian FDA review time

147 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K970441	K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH	Medi-Flex Hospital Products, Inc.	1997-05-09	93	0
K952947	DELPORE SKIN CLOSURE	Bitco Intl.	1995-07-24	28	0
K952702	DERMA SEAL	Ttl Medical	1995-06-28	15	0
K946321	BIOSTRIP STERILE WOUND CLOSURE STRIP	Cornelia Damsky, Inc.	1995-01-12	15	0
K931005	DUKAL SKIN CLOSURE STRIP	Dukal Corp.	1993-07-14	138	0
K921775	SPYROFLEX WOUND CLOSURES	Polymint Industrial Co. , Ltd.	1992-05-19	39	0
K894802	AWC BUTTERFLY WOUND CLOSURES	American White Cross, Inc.	1990-01-31	187	0
K894205	TECNOL SILK STRIP	Tecnol New Jersey Wound Care, Inc.	1989-07-25	36	0
K874813	OMED WOUND CLOSURE STRIPS	Oxboro Medical Intl., Inc.	1988-01-29	66	1
K840945	SKIN CLOSURE	Gainor Medical	1984-10-31	240	0
K842621	SUTURE STRIP	Genetic Laboratories, Inc.	1984-10-25	112	0
K833258	SKIN TECH. SURGI-STRIPS	Lee Tec Corp.	1984-01-25	127	0
K833083	DERMA STRIP-TM SKIN CLOSURES	Howmedica Corp.	1983-12-30	109	0
K831438	ELASTOPLAST	Beiersdorf, Inc.	1983-11-25	204	0
K831439	ELASTOPLAST T.P.N.	Beiersdorf, Inc.	1983-09-29	147	0
K821763	SHUR-STRIP APPLICATOR	Shur Medical Corp.	1982-06-23	8	0
K802385	CUSTOM DRESSING TRAY-WET TO DRY/MASS.	American Medical Disposable, Inc.	1980-11-12	41	0
K802384	CENTRAL VENOUS CATHETER DRESSING TRAY	American Medical Disposable, Inc.	1980-11-12	41	0
K801837	PLASTIC STRIP BANDAGES	Martin'S Maine Exchange	1980-10-31	91	0
K801884	OP-SITE SKIN CLOSURE SUTURE ADHESIVE	Acme United Corp.	1980-10-10	64	0
K792725	FIXOMULL	Beiersdorf, Inc.	1980-03-05	65	0
K792726	LEUKOFIX POROS	Beiersdorf, Inc.	1980-02-28	59	0
K792667	LEUKOCLIP POROS	Beiersdorf, Inc.	1980-01-16	20	0
K792136	HYPO-ALLERGENIC PLASTIC TAPE	National Patent Development Corp.	1980-01-16	86	0
K792360	HANSAPOR STERILE	Beiersdorf, Inc.	1979-12-31	40	0
K790140	SKIN CLOSURE TAPES STERILE	Shur Medical Corp.	1979-02-27	39	0
K782003	BAND AID* ADHESIVE BANDAGES	Johnson & Johnson Professionals, Inc.	1979-01-17	44	0
K781952	PAPER TAPE, HYPO ALLERGENIC	Johnson & Johnson Professionals, Inc.	1978-12-07	16	0
K780565	SUTURELESS SKIN CLOSURE	Abbott Laboratories	1978-07-07	92	0
K772020	CLOTH ADHESIVE TAPE	Johnson & Johnson Professionals, Inc.	1977-11-02	7	0
K771125	POLYURETHANE PROD. FOR I.V. NEEDLES	Devon Industries, Inc.	1977-08-02	41	0
K770533	BAND-AID BRAND ADHES. BAND.-SHEER STRIPS	Johnson & Johnson Professionals, Inc.	1977-06-07	78	0
K770081	BAND-AID BRAND OF ADHESIVE BANDAGES	Johnson & Johnson Professionals, Inc.	1977-03-09	54	0
K770339	BANDAGE, PLASTIC & SHEER	Johnson & Johnson Professionals, Inc.	1977-02-28	10	0
K770180	SUB. OF DIACETONE ACRYLAMIDE	Johnson & Johnson Professionals, Inc.	1977-02-15	19	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