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

Maxxim Medical — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

140 daysmedian FDA review time

302 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023236	SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLO	Maxxim Medical	2002-11-12	46	0
K021452	STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/	Maxxim Medical	2002-08-01	87	0
K011905	SNIPER ELITE MODEL-OR-E3872XX SERIES	Maxxim Medical	2001-08-28	70	52
K002847	INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926	Maxxim Medical	2001-05-31	260	0
K010297	SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRE	Maxxim Medical	2001-02-16	16	0
K002933	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICA	Maxxim Medical	2000-10-19	29	0
K990173	PATHFINDER II ANGIOGRAPHIC CATHETER	Maxxim Medical	1999-12-21	336	0
K992865	SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE	Maxxim Medical	1999-10-13	49	0
K991615	POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETH	Maxxim Medical	1999-07-30	81	0
K992122	TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE	Maxxim Medical	1999-07-15	22	0
K984189	ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER	Maxxim Medical	1999-05-05	163	0
K983982	SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES	Maxxim Medical	1999-05-04	176	0
K972071	BOVIE MODEL X40	Maxxim Medical	1997-10-21	140	0
K972161	BOVIE MODEL X15	Maxxim Medical	1997-06-18	9	0
K964440	EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GL	Maxxim Medical	1997-04-22	167	0
K963388	VESSEL DILATOR	Maxxim Medical	1997-03-11	195	0
K964962	SENTURA SURGICAL GLOVES	Maxxim Medical	1997-03-06	85	0
K964980	ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGIC	Maxxim Medical	1997-03-06	83	0
K962813	DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES	Maxxim Medical	1997-01-30	195	0
K963749	HIGH PRESSURE INJECTION LINES	Maxxim Medical	1996-12-17	90	0
K962513	DERMAPLEX HYDROGEL WOUND DRESSING	Maxxim Medical	1996-09-12	77	0
K954325	NEOLON NEOPRENE SURGICAL GLOVES	Maxxim Medical	1996-05-14	242	0
K935868	DYNAPHOR(TM) TWO	Maxxim Medical	1995-03-15	464	0
K941986	CUTANEOUS ELECTRODE	Maxxim Medical	1995-02-21	302	0
K943674	NEUTRALON LP BROWN LATEX SURGICAL GLOVES	Maxxim Medical	1995-02-13	202	0
K933560	BARRIER PLASTIC PACKAGING (MODIFICATION)	Maxxim Medical	1994-04-11	263	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