FDA applicant
Asahi Medical Co., Ltd.
FDA records 16 decisions for Asahi Medical Co., Ltd. (Washington, DC) from 1983 to 2004: 16 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FJI (Dialyzer, Capillary, Hollow Fiber). Its devices cite 7 predicates, 6 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 Medical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Asahi Medical Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Asahi 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.