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

FDA lists 1,334 510(k) clearances, 53 PMA and 9 De Novo decisions across the 24 applicant names Caduvo groups under Roche Diagnostics, first 1976, latest 2026. Median 510(k) review time across these names: 64 days. Since 2017 the median was 168 days, against 161 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 24 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 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.

Top product codes

Plus 340 more product codes.

Review panels

• Clinical Chemistry (703)
• Clinical Toxicology (285)
• Immunology (132)
• Microbiology (127)
• Hematology (58)
• Pathology (51)
• General Hospital (23)
• General and Plastic Surgery (8)
• Anesthesiology (1)
• Medical Genetics (1)
• Neurology (1)
• Orthopedic (1)
• Radiology (1)

Most recent Roche Diagnostics 510(k) clearances

1,324 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

576 product recalls in 269 recall events under these names; 20 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.

Boehringer Mannheim (1998), Disetronic (2003), Ventana Medical Systems (2008), GenMark (2021). Includes filings made before each acquisition. HOFFMANN-LA ROCHE is the parent's own 1976–1985 filings. Left out: Roche Medical Electronics (1970s monitoring business, later sold) and two small names with unclear history.

Sources

• https://en.wikipedia.org/wiki/Roche_Diagnostics
• https://en.wikipedia.org/wiki/Ventana_Medical_Systems
• https://en.wikipedia.org/wiki/Boehringer_Mannheim

Frequently asked questions

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

FDA lists 1,334 510(k) clearances, 53 PMA and 9 De Novo decisions across the 24 applicant names Caduvo groups under Roche Diagnostics, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Roche Diagnostics file under?

The names with the most 510(k) clearances in this group are Roche Diagnostics Corp. (456); Boehringer Mannheim Corp. (340); Roche Diagnostic Systems, Inc. (296); Roche Molecular Systems, Inc. (52); Hoffmann-La Roche, Inc. (49). The full list of 24 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 64 days. Since 2017 the median was 168 days, against 161 days for all cleared 510(k)s in the same product codes.

Does the Roche Diagnostics 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 1,334 Roche Diagnostics clearances with predicates and recalls
• Run predicate analysis for product code JJX, Roche Diagnostics'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