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

Venospital, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
78 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791130FLU-VEN TK-2Venospital, Inc.1979-09-04780
K791131FLU VEN TR-1Venospital, Inc.1979-09-04780
K790077BIOSTIL # 3884Venospital, Inc.1979-04-301090
K790424FLU-VEN 01510Venospital, Inc.1979-04-30600
K781184INFUSION SET, VENOTHIN 19Venospital, Inc.1978-08-10270
K781188INFUSION SET, VENOTHIN 25Venospital, Inc.1978-08-10270
K781186INFUSION, VENOTHIN 23Venospital, Inc.1978-08-10270
K781189FLU VEN 0151Venospital, Inc.1978-08-10270
K781190INFUSION SET, VENOTHIN 21Venospital, Inc.1978-08-10270
K781187INFUSION SET W/ INJECTION SITE, 23D-WVenospital, Inc.1978-08-10270
K781185INFUSION SET W/ INJECTION SITEVenospital, Inc.1978-08-10270
K771362FLU VEN 0150Venospital, Inc.1977-08-22350
K770864HEMODIALYSIS FISTULA SETVenospital, Inc.1977-06-24440
K770863FLU VEN 0160Venospital, Inc.1977-06-14340

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