FDA applicant
Ashai Co., Ltd.
FDA records 12 decisions for Ashai Co., Ltd. (Australia, AU) from 1985 to 1987: 12 510(k) clearances. Most are in product codes BYG (Mask, Oxygen) and CAT (Cannula, Nasal, Oxygen). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ashai Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ashai Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ashai 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