Atlas FDA

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

Seare Biomedical Corp. — Predicate Candidate Screening

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

55 daysmedian FDA review time
57 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983792SEARE BIOMEDICAL SILICONE TISSUE EXPANDERSeare Biomedical Corp.1998-12-11450
K983630SEARE BIOMEDICAL SILICONE RODSSeare Biomedical Corp.1998-12-11570
K982753SEARE BIOMEDICAL NASAL IMPLANTSSeare Biomedical Corp.1998-09-30550
K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.1998-09-30550
K982752SEARE BIOMEDICAL CHIN IMPLANTSSeare Biomedical Corp.1998-09-30550
K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.1998-09-30550
K983041SEARE BIOMEDICAL SILICONE SHEETINGSeare Biomedical Corp.1998-09-30300
K983043SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.1998-09-30300

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