Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
bioMérieux SA — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026-04-21 | 69 | 0 |
| K210793 | VIDAS NEPHROCHECK | Biomérieux SA | 2022-07-08 | 479 | 0 |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) | Biomérieux SA | 2020-05-07 | 66 | 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