bioMerieux, Inc.: FDA filings under this applicant name
FDA lists 257 510(k) clearances under 4 spellings of the applicant name “bioMerieux, Inc.” (first 1983, latest 2026), plus 3 PMA and 1 De Novo decisions, across 48 product codes in 5 review panels. Median 510(k) review time under this name: 59 days. Since 2017 the median was 90 days, against 90 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 | 12 | 206 |
| 2013 | 6 | 182 |
| 2014 | 3 | 232 |
| 2015 | 1 | 434 |
| 2016 | 7 | 227 |
| 2017 | 15 | 90 |
| 2018 | 3 | 160 |
| 2019 | 9 | 84 |
| 2020 | 4 | 67 |
| 2021 | 5 | 268 |
| 2022 | 8 | 189 |
| 2023 | 8 | 94 |
| 2024 | 4 | 175 |
| 2025 | 3 | 90 |
| 2026 | 3 | 76 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name bioMerieux, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 115 | 115 |
| JSJ | Culture Media, Selective And Non-Differential | 18 | 18 |
| JSG | Culture Media, Non-Selective And Non-Differential | 13 | 13 |
| JSH | Culture Media, Non-Selective And Differential | 12 | 12 |
| MDB | System, Blood Culturing | 12 | 12 |
| JSI | Culture Media, Selective And Differential | 11 | 11 |
| NGZ | Susceptibility Test Plate, Antifungal | 10 | 10 |
| JSF | Culture Media, Single Biochemical Test | 7 | 7 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 6 | 6 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 4 | 4 |
Plus 38 more product codes.
Review panels
- Microbiology (236)
- Clinical Chemistry (8)
- Hematology (8)
- Immunology (8)
- Pathology (1)
Most recent bioMerieux, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | SAN | 2026-07-08 | 169 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | LON | 2026-04-15 | 76 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | LON | 2026-03-26 | 56 |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | LON | 2025-08-21 | 90 |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | JWY | 2025-06-12 | 83 |
| K234012 | VITEK COMPACT PRO | LON | 2025-03-14 | 451 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | 2024-06-12 | 265 |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | 2024-06-07 | 260 |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | 2024-05-01 | 90 |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | LON | 2024-03-11 | 84 |
247 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130013 | De Novo | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | 2013-08-21 |
| P120014 | PMA | BIOMERIEUX THXID BRAF ASSAY KIT | 2013-05-29 |
| P080008 | PMA | VIDAS FREE PSA RT ASSAY | 2009-10-08 |
| P040008 | PMA | VIDAS TPSA ASSAY | 2004-07-08 |
Recalls
589 product recalls in 95 recall events; 106 initiated in the last five years. Most recent: 2026-07-24.
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.
Device clinical trials
An industry sponsor named bioMerieux, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07513519: Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial (Recruiting, started 2025-12-22)
- NCT06037109: VIDAS® NEPHROCLEAR Reference Interval Study (Completed, started 2023-07-18)
FDA spellings included
FDA records this applicant under 4 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- bioMerieux, Inc. (255)
- BIOMERIEUX (3)
- Biomérieux (2)
- Biomérieux, Inc. (1)
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 Vitek, Inc. (49 510(k)s)
- Biomerieux S.A. (16 510(k)s)
- Biomérieux SA (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under bioMerieux, Inc.?
FDA lists 257 510(k) clearances under 4 spellings of the applicant name “bioMerieux, Inc.” (first 1983, latest 2026), plus 3 PMA and 1 De Novo decisions, across 48 product codes in 5 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name bioMerieux, Inc. is 59 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under bioMerieux, Inc.?
The most frequent FDA product codes under this applicant name are LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, 115); JSJ (Culture Media, Selective And Non-Differential, 18); JSG (Culture Media, Non-Selective And Non-Differential, 13).
Next steps
- See all 257 bioMerieux, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LON, bioMerieux, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.