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

Strato Medical Corp. — Predicate Candidate Screening

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

113 daysmedian FDA review time

426 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K945956	STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER	Strato Medical Corp.	1995-06-06	182	0
K946250	STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CEN	Strato Medical Corp.	1995-05-02	130	0
K942848	STRATO MEDICAL LIFEPORT LPS 7515	Strato Medical Corp.	1995-02-01	230	0
K934518	STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERA	Strato Medical Corp.	1995-01-27	497	0
K932509	STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT	Strato Medical Corp.	1994-01-07	227	0
K933884	STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASC	Strato Medical Corp.	1993-12-30	142	0
K924851	STRATO MEDICAL SINGLE LUMEN VALVED CATHETER	Strato Medical Corp.	1993-12-13	441	0
K924677	STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH	Strato Medical Corp.	1993-07-30	317	0
K921751	INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER	Strato Medical Corp.	1993-07-07	450	0
K915273	LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555	Strato Medical Corp.	1993-07-07	590	1
K924505	SNAP-LOCK MICROPORT - REVISED	Strato Medical Corp.	1993-06-17	286	0
K921674	LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE	Strato Medical Corp.	1992-09-23	168	0
K911782	PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM	Strato Medical Corp.	1991-11-22	214	0
K905849	STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF	Strato Medical Corp.	1991-04-19	113	0
K905845	STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED	Strato Medical Corp.	1991-04-19	113	1
K905838	STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED	Strato Medical Corp.	1991-04-19	113	0
K905841	STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED	Strato Medical Corp.	1991-04-19	113	0
K905850	STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED	Strato Medical Corp.	1991-04-19	113	0
K905839	STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED	Strato Medical Corp.	1991-04-19	113	1
K905840	STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED	Strato Medical Corp.	1991-04-19	113	1
K905852	STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED	Strato Medical Corp.	1991-04-19	113	0
K905842	STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED	Strato Medical Corp.	1991-04-19	113	0
K905843	STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF	Strato Medical Corp.	1991-04-19	113	0
K911355	LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015	Strato Medical Corp.	1991-04-15	53	1
K905848	LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI	Strato Medical Corp.	1991-04-08	102	0
K905846	STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION	Strato Medical Corp.	1991-04-08	102	0
K905847	STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION	Strato Medical Corp.	1991-04-05	99	0
K905851	STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED	Strato Medical Corp.	1991-04-05	99	0
K905844	STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED	Strato Medical Corp.	1991-04-03	97	0
K905696	STRATOFUSE PCA INFUSER	Strato Medical Corp.	1991-03-08	77	0
K895543	WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER	Strato Medical Corp.	1990-09-21	373	0
K896598	STRATO INDWELLING CATHETER	Strato Medical Corp.	1990-04-25	155	0
K895689	LIFEPORT VASCULAR ACCESS PORT	Strato Medical Corp.	1989-12-27	96	0
K895871	LIFEPORT POLYURETHANE CATHETER	Strato Medical Corp.	1989-11-17	44	0
K881075	LIFEPORT II, MODEL LPS-1100	Strato Medical Corp.	1988-06-03	81	0
K880305	LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.	Strato Medical Corp.	1988-04-26	92	0
K870886	LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER	Strato Medical Corp.	1987-05-06	62	0
K870582	LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE	Strato Medical Corp.	1987-04-23	71	0
K870581	LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET	Strato Medical Corp.	1987-04-23	71	0
K864808	STRATO(R) PCA INFUSER	Strato Medical Corp.	1987-01-21	43	0
K853827	LIFE-PORT IMPLANTABLE VASCULAR ACCESS	Strato Medical Corp.	1986-11-13	426	0
K854318	LIFEPORT AMBULATORY INFUSION PUMP	Strato Medical Corp.	1986-03-18	141	0
K850488	STRATOFUSE SYRINGE PIGGYBACK PUMP 1030	Strato Medical Corp.	1985-03-21	42	0
K844627	STRATOFUSE SYRINGE PIGGYBACK PUMP	Strato Medical Corp.	1985-01-28	62	0
K843249	T-TYPE IV EXTENSION SET	Strato Medical Corp.	1984-09-07	18	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