Atlas FDA

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

Bio-Plexus, Inc. — Predicate Candidate Screening

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

174 daysmedian FDA review time
409 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003827PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTIONBio-Plexus, Inc.2001-01-08280
K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750Bio-Plexus, Inc.1999-09-09800
K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERBio-Plexus, Inc.1997-06-062620
K960933BIO-PLEXUS NEEDLE DISPOSAL CONTAINERBio-Plexus, Inc.1996-08-281740
K961251PUNCTUR-GUARD WINGED SETBio-Plexus, Inc.1996-06-27870
K895024PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLEBio-Plexus, Inc.1990-09-214090

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