FDA applicant
Hamamatsu Photonics K.K.
FDA records 10 decisions for Hamamatsu Photonics K.K. (Hamamatsu City, JP) from 1989 to 2026: 10 510(k) clearances. Most are in product codes PSY (Whole Slide Imaging System) and MUD (Oximeter, Tissue Saturation). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 253 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hamamatsu Photonics K.K.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Hamamatsu Photonics K.K.’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) Report