Thermo Fisher Scientific: FDA 510(k) clearances across all its applicant names

FDA lists 930 510(k) clearances, 4 PMA and 4 De Novo decisions across the 30 applicant names Caduvo groups under Thermo Fisher Scientific, first 1976, latest 2026. Median 510(k) review time across these names: 66 days. Since 2017 the median was 99 days, against 144 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 30 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 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.

Top product codes

Plus 246 more product codes.

Review panels

• Microbiology (435)
• Immunology (219)
• Clinical Chemistry (120)
• Clinical Toxicology (115)
• Hematology (23)
• Pathology (15)
• Gastroenterology and Urology (5)
• Obstetrics and Gynecology (3)
• General Hospital (1)

Most recent Thermo Fisher Scientific 510(k) clearances

920 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

203 product recalls in 141 recall events under these names; 34 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.

Thermo Electron merged with Fisher Scientific in 2006. Acquisitions: Microgenics (2000), Oxoid (Fisher, 2004), Remel (Fisher, via Apogent 2004), Phadia (2011), Life Technologies incl. Invitrogen and Applied Biosystems (2014), One Lambda (2012), The Binding Site (2023). Includes filings made before each acquisition. Left out: Thermo Cardiosystems (now Abbott via Thoratec), ThermoScan (Braun) and other THERMO-named unrelated firms.

Sources

• https://en.wikipedia.org/wiki/Thermo_Fisher_Scientific
• https://en.wikipedia.org/wiki/Life_Technologies_(Thermo_Fisher_Scientific)
• https://en.wikipedia.org/wiki/Phadia

Frequently asked questions

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

FDA lists 930 510(k) clearances, 4 PMA and 4 De Novo decisions across the 30 applicant names Caduvo groups under Thermo Fisher Scientific, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Thermo Fisher Scientific file under?

The names with the most 510(k) clearances in this group are Remel Co. (154); Microgenics Corp. (126); The Binding Site, Ltd. (125); Oxoid U.S.A., Inc. (93); Fisher Scientific Co., LLC (89). The full list of 30 names is on this page.

How long does FDA take to clear Thermo Fisher Scientific 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 66 days. Since 2017 the median was 99 days, against 144 days for all cleared 510(k)s in the same product codes.

Does the Thermo Fisher Scientific 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 930 Thermo Fisher Scientific clearances with predicates and recalls
• Run predicate analysis for product code JTO, Thermo Fisher Scientific'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.

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