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

FQM — Predicate Candidate Screening

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

27 daysmedian FDA review time

106 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K040936	PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE	Leda Co., Ltd.	2004-05-03	24
K040054	BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LO	Theodore Barash	2004-04-27	106
K013244	COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICR	Med Gen, Inc.	2001-12-07	70
K952738	SKIN SAVER SYSTEMS	Skin Saver Systems, Inc.	1995-09-29	107
K872868	ASPEN ESMARK BANDAGE	Aspen Laboratories, Inc.	1987-07-31	10
K840107	TUBE-BANDAGE FOR HUMAN DIGITS 200	Zens Health Care Products	1984-04-25	106
K831728	MEDICALEX	Medicalex	1984-01-09	223
K830622	ORTHO WRAP	Fast Wrap Co., Inc.	1983-06-20	112
K831551	COMPRESSOGRIP TUBULAR ELASTIC BANDAGE	Fred Sammons, Inc.	1983-06-07	26
K820141	BIAS STOCKINETTE	Stan-Pak Ent.	1982-02-05	17
K820142	TUBULAR STOCKINETTE	Stan-Pak Ent.	1982-02-05	17
K820094	ELASTIC BANDAGE	Stan-Pak Ent.	1982-01-29	16
K811173	STRUVA & MEDI	Weco	1981-06-18	51
K810137	SOF-BAND HIGH STRETCH BANDAGES	Johnson & Johnson Professionals, Inc.	1981-02-17	27
K802991	ROLL STRETCH GAUZE	Abco Dealers, Inc.	1980-12-30	39
K802992	ELASTIC GAUZE	Abco Dealers, Inc.	1980-12-30	39
K802785	ELASTIC BANDAGE	Secol Co.	1980-12-11	37
K802784	ELASTIC OPEN WEAVE BANDAGE	Secol Co.	1980-12-10	36
K802789	TUBULAR BANDAGE	Secol Co.	1980-12-10	36
K802015	FINGER PAINGUARD CAT.#193-194	Pollak (Intl.), Ltd.	1980-09-09	20
K801990	ELASTIC BANDAGE CAT.#182-186 (WIDTH)	Pollak (Intl.), Ltd.	1980-09-09	20
K801532	STOCKINETTE, STERILE TWO PLY W/PULL TABS	The Owenby Co.	1980-07-28	27
K801458	WINTER HEAD DRESSING	Steridyne Corp.	1980-07-28	34
K800280	MEDSPEC RUBBER ELASTIC BANDAGES	Medspec Corp.	1980-03-12	36
K800197	ANAGO DISP., ALL PURPOSE PATIENT REST.	Anago, Inc.	1980-02-26	27
K792331	TOMMY TOES	Tommy Toes	1979-12-20	31
K792065	POROUS ELASTIC RUBBER BANDAGE	Norman R. Sanborn Co.	1979-11-20	36
K791256	SECUTEX SURGICAL BINDER	Conphar, Inc.	1979-08-03	28
K791211	BINDAFIX	Conphar, Inc.	1979-08-03	32
K790210	STOCKINETTE, TUBULAR UNBLEACHED	The Owenby Co.	1979-02-27	28
K781931	TAPE, ELASTOPLAST ELASTIC TEAR	Beiersdorf, Inc.	1978-12-07	17
K780606	BANDAGE	Abco Dealers, Inc.	1978-04-19	9
K780570	TUBULAR DRESSING RETAINER	Alba-Waldensian, Inc.	1978-04-19	9
K780231	BANDAGE, ELASTIC	Biomet, Inc.	1978-02-21	12
K771758	ELASTOMULL GAUZE BANDAGE	Beiersdorf, Inc.	1977-10-13	24
K771563	CONFORM ELASTIC NETTING	Kendall Research Center	1977-09-12	28
K770958	BANDAGE, UNIPRESS, CLARION	Sherwood Medical Industries	1977-06-14	18
K760139	BANDAGE, E-COTTON ELASTIC	Conco Medical Co.	1976-07-19	20
K760142	BANDAGE, RAPIDO-LASTIC COTTON/NYLON	Conco Medical Co.	1976-07-19	20
K760140	BANDAGE, WRINKY-LASTIC ELASTIC GAUZE	Conco Medical Co.	1976-07-19	20
K760138	BANDAGE, CEB COTTON ELASTIC	Conco Medical Co.	1976-07-19	20
K760141	BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC	Conco Medical Co.	1976-07-19	20

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