FDA applicant
Olympus Surgical Technologies America
FDA records 14 decisions for Olympus Surgical Technologies America (Southborough, MA) from 2012 to 2026: 14 510(k) clearances. Most are in product codes KTI (Bronchoscope Accessory) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 3 of them its own earlier devices. 24 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Olympus Surgical Technologies America’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
7in 2026
Class I Class II/III not classified
Planning a device like Olympus Surgical Technologies America’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.