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

FDA lists 744 510(k) clearances, 2 PMA and 0 De Novo decisions across the 25 applicant names Caduvo groups under Olympus, first 1978, latest 2026. Median 510(k) review time across these names: 91 days. Since 2017 the median was 124 days, against 115 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 25 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 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.

Top product codes

Plus 170 more product codes.

Review panels

• Gastroenterology and Urology (264)
• General and Plastic Surgery (127)
• Clinical Chemistry (105)
• Ear, Nose and Throat (101)
• Obstetrics and Gynecology (45)
• Radiology (34)
• Immunology (19)
• General Hospital (17)
• Cardiovascular (9)
• Anesthesiology (6)
• Neurology (6)
• Orthopedic (4)
• Microbiology (3)
• Hematology (2)
• Dental (1)
• Ophthalmic (1)
• Clinical Toxicology (1)

Most recent Olympus 510(k) clearances

734 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

621 product recalls in 182 recall events under these names; 367 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.

Gyrus Group incl. ACMI/Circon (2008), Spiration (2010), Veran Medical (2023). Includes filings made before each acquisition. Left out: life-science and scientific-equipment names (Evident, sold 2023), Olympus Diagnostica (lab diagnostics sold to Beckman Coulter 2009), Olympus Terumo Biomaterials (joint venture). The OLYMPUS / OLYMPUS AMERICA names may include some pre-2023 microscope filings.

Sources

• https://en.wikipedia.org/wiki/Olympus_Corporation

Frequently asked questions

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

FDA lists 744 510(k) clearances, 2 PMA and 0 De Novo decisions across the 25 applicant names Caduvo groups under Olympus, first 1978, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Olympus file under?

The names with the most 510(k) clearances in this group are Olympus Medical Systems Corp. (190); Olympus Corp. (149); Olympus America, Inc. (149); Gyrus Acmi, Inc. (43); Olympus Winter & Ibe GmbH (43). The full list of 25 names is on this page.

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

The median time from FDA receipt to decision across 510(k)s cleared under these names is 91 days. Since 2017 the median was 124 days, against 115 days for all cleared 510(k)s in the same product codes.

Does the Olympus 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 744 Olympus clearances with predicates and recalls
• Run predicate analysis for product code GEI, Olympus'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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