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

Bipore, Inc. — Predicate Candidate Screening

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

117 daysmedian FDA review time
194 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073434BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERBipore, Inc.2008-04-011170
K073318BIPORE BALLOON DILATION CATHETERBipore, Inc.2008-01-16510
K051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERBipore, Inc.2005-12-071880
K041293BIOPORE BALLOON DILATION CATHETERBipore, Inc.2004-07-09560
K983650BIPORE BALLOON DILATATION CATHETERBipore, Inc.1999-02-171240
K973563BIPORE BALLOON DILATATION CATHETERBipore, Inc.1998-04-011940
K964814BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERBipore, Inc.1997-05-071590
K961980BIPORE BALLOON DILATATION CATHETERBipore, Inc.1996-09-121150
K862015O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTERBipore, Inc.1986-07-22550
K844625BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLYBipore, Inc.1985-01-16500

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