FDA applicant
Olympus Medical Systems Corp.
FDA records 190 decisions for Olympus Medical Systems Corp. (Hachioji-Shi, JP) from 2004 to 2026: 190 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 305 predicates, 144 of them its own earlier devices. 300 recalls are linked to its devices, 24 Class I.
FDA’s records also spell it “Olympus Medical Systems Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Medical Systems Corp.’s devices, and how often a recall has named them.
FDA decisions per year
32in 2025
2026 so far, outlined.
Recalls per year
42in 2026
Class I Class II/III not classified
Planning a device like Olympus Medical Systems Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Olympus”
FDA records each applicant name separately; these may or may not be the same firm.