FDA applicant
Asahi Kasei Medical Co., Ltd.
FDA records 6 decisions for Asahi Kasei Medical Co., Ltd. (Chiyoda-Ku, JP) from 1983 to 2017: 5 510(k) clearances and 1 original PMA approval. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and MDP (Separator For Therapeutic Purposes, Membrane…). Its devices cite 18 predicates, 4 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Asahi Kasei Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
7in 2012
Class I Class II/III not classified
Planning a device like Asahi Kasei Medical 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) ReportOther applicant names beginning “Asahi”
FDA records each applicant name separately; these may or may not be the same firm.