Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid): FDA 510(k) clearances across all its applicant names

FDA lists 1,096 510(k) clearances, 6 PMA and 4 De Novo decisions across the 36 applicant names Caduvo groups under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), first 1976, latest 2026. Median 510(k) review time across these names: 68 days. Since 2017 the median was 157 days, against 172 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 36 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 157 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.

Top product codes

Plus 306 more product codes.

Review panels

• Clinical Chemistry (511)
• Hematology (181)
• Microbiology (167)
• Immunology (118)
• Clinical Toxicology (81)
• Pathology (25)
• Anesthesiology (11)
• General Hospital (2)
• Neurology (2)
• Cardiovascular (1)
• Dental (1)
• Radiology (1)

Most recent Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) 510(k) clearances

1,086 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

780 product recalls in 526 recall events under these names; 122 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.

Radiometer (2004), Leica (2005), HemoCue (2013 via Radiometer), Beckman Coulter (2011; Beckman had merged with Coulter 1997 and bought Hybritech and Immunotech), IRIS International (2012), Cepheid (2016), MicroScan (from Siemens, 2018) and Olympus's lab-diagnostics business (2009). Includes filings made before each acquisition. Left out: Leica Microsystems (microscopy), dental businesses (spun off as Envista 2019).

Sources

• https://en.wikipedia.org/wiki/Danaher_Corporation
• https://en.wikipedia.org/wiki/Beckman_Coulter
• https://en.wikipedia.org/wiki/Cepheid_(company)
• https://en.wikipedia.org/wiki/Radiometer_(company)

Frequently asked questions

How many FDA 510(k) clearances are listed across Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid)'s applicant names?

FDA lists 1,096 510(k) clearances, 6 PMA and 4 De Novo decisions across the 36 applicant names Caduvo groups under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) file under?

The names with the most 510(k) clearances in this group are Beckman Instruments, Inc. (281); Beckman Coulter, Inc. (277); Coulter Electronics, Inc. (101); Hybritech, Inc. (63); Coulter Corp. (51). The full list of 36 names is on this page.

How long does FDA take to clear Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 68 days. Since 2017 the median was 157 days, against 172 days for all cleared 510(k)s in the same product codes.

Does the Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) 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 1,096 Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) clearances with predicates and recalls
• Run predicate analysis for product code GKZ, Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid)'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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