Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomerix Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
326 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112499 | BIOMERIX COMPOSITE SURGICAL MESH | Biomerix Corporation | 2011-12-23 | 115 | 0 |
| K112567 | BIOMERIX ASSURE | Biomerix Corporation | 2011-12-23 | 112 | 0 |
| K093123 | BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB | Biomerix Corporation | 2010-05-13 | 223 | 0 |
| K082941 | BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1 | Biomerix Corporation | 2009-01-07 | 97 | 0 |
| K070961 | BIOMERIX SURGICAL MESH, MODEL: RCR-01 | Biomerix Corporation | 2008-02-25 | 326 | 0 |
| K043371 | BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER | Biomerix Corporation | 2005-02-03 | 57 | 0 |
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