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

Omega Silicone, Inc. — Predicate Candidate Screening

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

54 daysmedian FDA review time
82 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, Inc.1987-06-08820
K871070OMEGA SILICONE CHIN IMPLANTOmega Silicone, Inc.1987-05-11540
K871073OMEGA BIVALVE NASAL SPLINTSOmega Silicone, Inc.1987-05-11540
K871071OMEGA DORSAL COLUMELLA IMPLANTSOmega Silicone, Inc.1987-04-13260
K871074OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAROmega Silicone, Inc.1987-04-10230

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