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

Impra, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
176 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTSImpra, Inc.2001-05-141380
K004011IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTImpra, Inc.2001-03-27900
K991027BI-DIRECTIONAL TUNNELERImpra, Inc.1999-04-22240
K983769DISTAFLO BYPASS GRAFTImpra, Inc.1998-12-15500
K983861DISTAFLO BYPASS GRAFTImpra, Inc.1998-11-24222
K983064IMPRA HIGH POROSITY GRAFTImpra, Inc.1998-11-19780
K981079VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAImpra, Inc.1998-05-07440
K981076VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAImpra, Inc.1998-05-07440
K971192IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTImpra, Inc.1997-04-15150
K964877IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFTImpra, Inc.1997-03-201050
K964197IMPRA CARBOFLO EPTFE VASCULAR GRAFTImpra, Inc.1997-01-02730
K962639IMPRA CARBOFLO EPTFE VASCULAR GRAFTImpra, Inc.1996-10-03900
K925827IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANIImpra, Inc.1993-07-292550
K924360IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)Impra, Inc.1992-11-25890
K915577IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICEImpra, Inc.1992-03-11890
K905073CARDIOVASCULAR REPAIR PATCHImpra, Inc.1991-12-204060
K904515IMPRAFLO 3500 SERIESImpra, Inc.1990-12-04620
K901232IMPRAFLO AUTOTRANSFUSION DEVICEImpra, Inc.1990-07-181260
K900311ARTERIAL EMBOLECTOMY CATHETERImpra, Inc.1990-07-171760
K901133DURACATHImpra, Inc.1990-06-08880
K892819AUTOTRANSFUSION DEVICEImpra, Inc.1989-05-22350
K883592IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETERImpra, Inc.1988-12-081070
K87473810 AND 12 FRENCH VESSEL DILATORSImpra, Inc.1988-05-021660
K872163IMPRA DUAL LUMEN SUBCLAVIAN CATHETERImpra, Inc.1987-10-301470
K830543VASCULAR GRAFT PROSTHESIS EXPANDED MICRImpra, Inc.1983-07-191470
K823857IMPRA PERITONEAL CATHETERImpra, Inc.1983-01-26350
K812427CARTMILL/BARRY FEEDING TUBEImpra, Inc.1981-09-23290
K801621VASCULAR GRAFT PROSTH. OF EXP. MICRO.Impra, Inc.1980-09-09560
K791810VASCULAR GRAFT PROST. OF EXPANDED PTFEImpra, Inc.1979-10-09250

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