FDA applicant
Nikkiso CO., LTD.
FDA records 11 decisions for Nikkiso CO., LTD. (Shibuya-Ku, JP) from 1981 to 2025: 11 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and KOC (Accessories, Blood Circuit, Hemodialysis). Its devices cite 14 predicates, 7 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 Nikkiso CO., LTD.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Nikkiso CO., LTD.’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