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

FDA lists 3,732 510(k) clearances, 33 PMA and 2 De Novo decisions across the 65 applicant names Caduvo groups under Siemens Healthineers, first 1976, latest 2026. Median 510(k) review time across these names: 61 days. Since 2017 the median was 103 days, against 129 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 65 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 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.

Top product codes

Plus 523 more product codes.

Review panels

• Radiology (1,303)
• Clinical Chemistry (898)
• Clinical Toxicology (594)
• Immunology (290)
• Microbiology (238)
• Hematology (229)
• Cardiovascular (114)
• Anesthesiology (23)
• Pathology (9)
• General and Plastic Surgery (9)
• Dental (7)
• Gastroenterology and Urology (7)
• Ophthalmic (7)
• Neurology (5)
• Obstetrics and Gynecology (5)
• General Hospital (2)
• Ear, Nose and Throat (1)
• Orthopedic (1)

Most recent Siemens Healthineers 510(k) clearances

3,722 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2,162 product recalls in 1,147 recall events under these names; 299 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.

Acuson (2000), Diagnostic Products Corp (2006), Bayer Diagnostics (2007; earlier Technicon, Chiron Diagnostics and Ciba Corning Diagnostics), Dade Behring (2007; earlier American Dade/Baxter Diagnostics, Behring Diagnostics, Syva), Corindus (2019), Varian Medical Systems (2021; VARIAN ASSOC is Varian's pre-1999 parent name). Includes filings made before each acquisition. Left out: Siemens Medical Electronics (patient monitoring, moved to Dräger 2003), hearing instruments (sold 2015, now WS Audiology), Siemens-Elema ventilation (sold to Maquet/Getinge 2003), Siemens-Pacesetter (sold to St. Jude 1994), Siemens health IT (sold to Cerner 2015), MicroScan (sold to Beckman Coulter 2018).

Sources

• https://en.wikipedia.org/wiki/Siemens_Healthineers
• https://en.wikipedia.org/wiki/Dade_Behring
• https://en.wikipedia.org/wiki/Varian_Medical_Systems
• https://en.wikipedia.org/wiki/Acuson

Frequently asked questions

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

FDA lists 3,732 510(k) clearances, 33 PMA and 2 De Novo decisions across the 65 applicant names Caduvo groups under Siemens Healthineers, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Siemens Healthineers file under?

The names with the most 510(k) clearances in this group are Siemens Medical Solutions USA, Inc. (784); Syva Co. (448); Dade Behring, Inc. (343); Diagnostic Products Corp. (324); Siemens Healthcare Diagnostics, Inc. (245). The full list of 65 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 61 days. Since 2017 the median was 103 days, against 129 days for all cleared 510(k)s in the same product codes.

Does the Siemens Healthineers 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 3,732 Siemens Healthineers clearances with predicates and recalls
• Run predicate analysis for product code JAK, Siemens Healthineers'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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