Biomerieux S.A.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Biomerieux S.A.” (first 2011, latest 2025), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 78 days, against 85 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under bioMérieux, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 160 |
| 2014 | 0 | — |
| 2015 | 2 | 398 |
| 2016 | 0 | — |
| 2017 | 1 | 245 |
| 2018 | 2 | 78 |
| 2019 | 5 | 60 |
| 2020 | 0 | — |
| 2021 | 1 | 242 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomerieux S.A. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 85 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 10 | 10 |
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 | 1 |
| MCB | Antigen, C. Difficile | 1 | 1 |
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | 1 | 1 |
Review panels
- Microbiology (15)
- Clinical Chemistry (1)
Most recent Biomerieux S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | JWY | 2025-04-30 | 90 |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | JWY | 2021-11-12 | 242 |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | JWY | 2019-11-26 | 60 |
| K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) | JWY | 2019-09-27 | 58 |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | JWY | 2019-08-22 | 31 |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | JWY | 2019-05-01 | 91 |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | JWY | 2019-01-11 | 71 |
| K181092 | CHROMID CARBA agar (CARB) | JSO | 2018-07-06 | 72 |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | JWY | 2018-07-03 | 84 |
| K162385 | RAPIDEC CARBA NP | PTJ | 2017-04-27 | 245 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomerieux S.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- bioMerieux, Inc. (254 510(k)s)
- Biomerieux Vitek, Inc. (49 510(k)s)
- Biomerieux Sa, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomerieux S.A.?
FDA lists 16 510(k) clearances under the applicant name “Biomerieux S.A.” (first 2011, latest 2025), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biomerieux S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomerieux S.A. is 90 days. Since 2017: 78 days, versus 85 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biomerieux S.A.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 10); LSR (Reagent, Borrelia Serological Reagent, 2); CEC (Radioimmunoassay, Free Thyroxine, 1).
Next steps
- See all 16 Biomerieux S.A. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Biomerieux S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.