FDA applicant
Topcon Corporation
FDA records 23 decisions for Topcon Corporation (Tokyo, JP) from 2004 to 2026: 23 510(k) clearances. Most are in product codes OBO (Tomography, Optical Coherence) and HKI (Camera, Ophthalmic, Ac-Powered). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 18 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Topcon Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Topcon Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Topcon Corporation’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 “Topcon”
FDA records each applicant name separately; these may or may not be the same firm.