Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BIOMERIEUX · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
434 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | 2026-03-26 | 56 | 0 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | 2025-06-12 | 83 | 0 |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETE | Biomérieux | 2023-10-05 | 57 | 0 |
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB I | BIOMERIEUX | 2015-07-09 | 434 | 2 |
| K102668 | ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML | BIOMERIEUX | 2010-11-17 | 62 | 2 |
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