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

Convatec, A Bristol-Myers Squibb Co. — Predicate Candidate Screening

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

84 daysmedian FDA review time
271 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032734CONVATEC FECAL MANAGEMENT SYSTEMConvatec, A Bristol-Myers Squibb Co.2004-04-082173
K990368DUODERM HYDROACTIVE GEL WOUND DRESSINGConvatec, A Bristol-Myers Squibb Co.1999-03-26460
K982116AQUACEL HYDROFIBER WOUND DRESSINGConvatec, A Bristol-Myers Squibb Co.1998-09-08840
K973806DUODERM HYDROACTIVE GELConvatec, A Bristol-Myers Squibb Co.1997-12-29840
K973807DUODERM HYDROACTIVE PASTEConvatec, A Bristol-Myers Squibb Co.1997-12-23780
K973717COMBIDERM ACDConvatec, A Bristol-Myers Squibb Co.1997-12-17790
K973716DUODERM EXTRA THIN CGF DRESSINGConvatec, A Bristol-Myers Squibb Co.1997-12-17790
K954918COMBIDERM ACDConvatec, A Bristol-Myers Squibb Co.1995-12-26610
K942941CONQUEST MALE CONTINENCE SYSTEMConvatec, A Bristol-Myers Squibb Co.1995-03-172680
K940895EPIVIEWConvatec, A Bristol-Myers Squibb Co.1994-11-222710

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