Atlas FDA

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

Bio Med Sciences, Inc. — Predicate Candidate Screening

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

72 daysmedian FDA review time
244 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023136OLEEVA FABRICBio Med Sciences, Inc.2002-10-16260
K002109OLEEVA FOAMBio Med Sciences, Inc.2000-08-31500
K990042SILON DUAL-DRESSBio Med Sciences, Inc.1999-03-19720
K982036SILON SCAR STRIPSBio Med Sciences, Inc.1998-08-06570
K952546SILON SILICONE TEXTILE COMPOSITEBio Med Sciences, Inc.1995-08-07660
K946362SILON SILICONE FOAM SHEETINGBio Med Sciences, Inc.1995-07-132170
K945892SILON(R) SILICONE THERMOPLASTIC SHEETINGBio Med Sciences, Inc.1995-03-03910
K932214SILON SILICONE GEL SHEETBio Med Sciences, Inc.1994-01-062440
K923150SILON TRANSPARENT WOUND DRESSINGSBio Med Sciences, Inc.1992-08-27590
K912032SILON(TM) TRANSPARENT WOUND DRESSINGBio Med Sciences, Inc.1991-08-201040

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