Atlas FDA

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

Fidia Pharmaceutical Corp. — Predicate Candidate Screening

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

194 daysmedian FDA review time
357 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K984267MODIFICATION OF BIONECT HYDROGEL FOAMFidia Pharmaceutical Corp.1999-02-10850
K984413BIONECT HYDROGELFidia Pharmaceutical Corp.1999-02-10850
K984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADSFidia Pharmaceutical Corp.1999-02-10850
K984266MODIFICATION OF BIONECT HYDROGEL SPRAYFidia Pharmaceutical Corp.1999-02-10850
K984264MODIFICATION OF BIONECT CLEAR HYDROGELFidia Pharmaceutical Corp.1999-02-10850
K973724BIONECT HYDROGEL SPRAYFidia Pharmaceutical Corp.1998-09-223570
K973722BIONECT HYDROGEL FOAMFidia Pharmaceutical Corp.1998-09-223570
K973725BIONECT CLEAR HYDROGELFidia Pharmaceutical Corp.1998-09-223570
K973721BIONECT HYDROGEL GAUZE PADSFidia Pharmaceutical Corp.1998-09-223570
K963004BIONECT CREAMFidia Pharmaceutical Corp.1997-02-121940

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