Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomerieux S.A. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
255 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/ | Biomerieux S.A. | 2025-04-30 | 90 | 0 |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Biomerieux S.A. | 2021-11-12 | 242 | 0 |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | Biomerieux S.A. | 2019-11-26 | 60 | 0 |
| K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | Biomerieux S.A. | 2019-09-27 | 58 | 1 |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | Biomerieux S.A. | 2019-08-22 | 31 | 1 |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | Biomerieux S.A. | 2019-05-01 | 91 | 0 |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | Biomerieux S.A. | 2019-01-11 | 71 | 0 |
| K181092 | CHROMID CARBA agar (CARB) | Biomerieux S.A. | 2018-07-06 | 72 | 1 |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. | 2018-07-03 | 84 | 0 |
| K162385 | RAPIDEC CARBA NP | Biomerieux S.A. | 2017-04-27 | 245 | 0 |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Biomerieux S.A. | 2015-10-07 | 90 | 0 |
| K132058 | VIDAS FT4 | Biomerieux S.A. | 2015-06-08 | 705 | 0 |
| K132010 | VIDAS C DIFFICILE GDH | Biomerieux S.A. | 2013-10-09 | 100 | 0 |
| K122979 | VIDAS LYME IGM | Biomerieux S.A. | 2013-06-04 | 251 | 0 |
| K122986 | VIDAS LYME IGG | Biomerieux S.A. | 2013-03-05 | 160 | 0 |
| K102535 | ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML | Biomerieux S.A. | 2011-05-16 | 255 | 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