Olympus Medical Systems Corp.: FDA filings under this applicant name

FDA lists 190 510(k) clearances under the applicant name “Olympus Medical Systems Corp.” (first 2004, latest 2026), across 49 product codes in 7 review panels. Median 510(k) review time under this name: 120 days. Since 2017 the median was 124 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Olympus, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Olympus Medical Systems Corp. 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 118 days.

Top product codes

Plus 39 more product codes.

Review panels

• Gastroenterology and Urology (107)
• Ear, Nose and Throat (35)
• General and Plastic Surgery (21)
• Radiology (11)
• Obstetrics and Gynecology (10)
• General Hospital (5)
• Anesthesiology (1)

Most recent Olympus Medical Systems Corp. 510(k) clearances

180 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Olympus Medical Systems Corp..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Olympus Corp. (149 510(k)s)
• Olympus America, Inc. (149 510(k)s)
• Olympus Winter & Ibe GmbH (43 510(k)s)
• Olympus Optical Co., Ltd. (26 510(k)s)
• Olympus Surgical Technologies America (14 510(k)s)
• Olympus Diagnostica GmbH (4 510(k)s)
• Olympus Life & Material Science Europa GmbH (Irish (3 510(k)s)
• Olympus Life Science Research Europa GmbH (Europa) (3 510(k)s)
• Olympus Terumo Biomaterials Corporation (3 510(k)s)
• Olympus Corp of America (2 510(k)s)
• Olympus Opto-Electronics Co., Ltd. (2 510(k)s)
• Olympus America Inc. / Scientific Equipment Group (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Olympus Medical Systems Corp.?

FDA lists 190 510(k) clearances under the applicant name “Olympus Medical Systems Corp.” (first 2004, latest 2026), across 49 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Olympus Medical Systems Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Olympus Medical Systems Corp. is 120 days. Since 2017: 124 days, versus 118 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Olympus Medical Systems Corp.?

The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 19); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 10); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 10).

Next steps

• See all 190 Olympus Medical Systems Corp. clearances with predicates and recalls
• Run predicate analysis for product code EOQ, Olympus Medical Systems Corp.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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