bioMérieux: FDA 510(k) clearances across all its applicant names

FDA lists 402 510(k) clearances, 4 PMA and 7 De Novo decisions across the 9 applicant names Caduvo groups under bioMérieux, first 1978, latest 2026. Median 510(k) review time across these names: 80 days. Since 2017 the median was 90 days, against 98 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 9 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names 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 98 days.

Top product codes

Plus 114 more product codes.

Review panels

• Microbiology (340)
• Clinical Chemistry (26)
• Hematology (23)
• Immunology (11)
• Clinical Toxicology (8)
• Pathology (1)
• General and Plastic Surgery (1)

Most recent bioMérieux 510(k) clearances

392 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

682 product recalls in 154 recall events under these names; 136 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Vitek Systems (1988), Organon Teknika's diagnostics business (2001; the ORGANON TEKNIKA names are left out because that company also had other lines), BioFire (2014). Includes filings made before each acquisition. Left out: ORGANON (plain), which is a different, pharma-related applicant.

Sources

• https://en.wikipedia.org/wiki/BioM%C3%A9rieux
• https://en.wikipedia.org/wiki/BioFire_Diagnostics

Frequently asked questions

How many FDA 510(k) clearances are listed across bioMérieux's applicant names?

FDA lists 402 510(k) clearances, 4 PMA and 7 De Novo decisions across the 9 applicant names Caduvo groups under bioMérieux, first 1978, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does bioMérieux file under?

The names with the most 510(k) clearances in this group are bioMerieux, Inc. (254); Biomerieux Vitek, Inc. (49); Vitek Systems, Inc. (39); Biofire Diagnostics, LLC (31); Biomerieux S.A. (16). The full list of 9 names is on this page.

How long does FDA take to clear bioMérieux 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 80 days. Since 2017 the median was 90 days, against 98 days for all cleared 510(k)s in the same product codes.

Does the bioMérieux count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 402 bioMérieux clearances with predicates and recalls
• Run predicate analysis for product code LON, bioMérieux's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

All parent companies · FDA device companies by applicant name · FDA product code lookup