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

Vascular Technology Incorporated — Predicate Candidate Screening

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

42 daysmedian FDA review time

319 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K082870	VTI INTRAOPERATIVE DOPPLER SYSTEMS	Vascular Technology Incorporated	2008-10-28	29	4
K031091	VTI 20 MHZ GATED DOPPLER	Vascular Technology Incorporated	2003-04-23	16	0
K002990	VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW	Vascular Technology Incorporated	2000-11-06	42	0
K944764	VTI DISPOSABLE PRESSURE DISPLAY SET	Vascular Technology Incorporated	1994-12-27	91	0
K922738	VTI OXYGEN ANALYZER	Vascular Technology Incorporated	1993-01-27	233	0
K890058	VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM	Vascular Technology Incorporated	1989-11-21	319	0
K883960	GIPHY MONITOR	Vascular Technology Incorporated	1989-10-04	379	0
K864583	CARDIAC PERFORMANCE MONITOR	Vascular Technology Incorporated	1987-05-11	172	0
K862114	KHURI REGIONAL TISSUE PH MONITOR	Vascular Technology Incorporated	1986-06-25	22	0
K862113	NO. 100352 GALVANIC OXYGEN SENSOR	Vascular Technology Incorporated	1986-06-19	16	0
K852275	VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR	Vascular Technology Incorporated	1985-06-20	22	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