# Ashai Co., Ltd.

- Location (FDA's records): Australia, AU
- FDA decisions: 12 (1985–1987): 12 510(k) clearances
- Product codes: BYG (4), CAT (2), BTI (2), KNX (1), CCQ (1), HIS (1), BYF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K870428: Aerosol One, Nebulizer Pump (May 15, 1987)
- K852622: Aerosol One (Apr 24, 1986)
- K852620: Safe.N.Sure (Oct 31, 1985)
- K852627: Maxi-Neb (Sep 26, 1985)
- K852626: Aero-Mask One (Sep 18, 1985)
- K852628: Nasal One (Sep 18, 1985)
- K852625: Oxy-Tube (Sep 18, 1985)
- K852629: Aero-Mask Two (Sep 18, 1985)

Source page: https://510kreport.com/company/ashai