Ashai Co. , Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ashai Co. , Ltd.” (first 1985, latest 1987), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BYG | Mask, Oxygen | 4 | 4 |
| BTI | Compressor, Air, Portable | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 2 | 2 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| HIS | Condom | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Ashai Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870428 | AEROSOL ONE, NEBULIZER PUMP | BTI | 1987-05-15 | 101 |
| K852622 | AEROSOL ONE | BTI | 1986-04-24 | 308 |
| K852620 | SAFE.N.SURE | HIS | 1985-10-31 | 133 |
| K852627 | MAXI-NEB | CCQ | 1985-09-26 | 98 |
| K852629 | AERO-MASK TWO | BYG | 1985-09-18 | 90 |
| K852628 | NASAL ONE | CAT | 1985-09-18 | 90 |
| K852626 | AERO-MASK ONE | BYG | 1985-09-18 | 90 |
| K852625 | OXY-TUBE | CAT | 1985-09-18 | 90 |
| K852624 | OXY-TWO | BYG | 1985-09-18 | 90 |
| K852623 | OXY-ONE | BYG | 1985-09-18 | 90 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ashai Co. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ashai Co. , Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Ashai Co. , Ltd.” (first 1985, latest 1987), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ashai Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ashai Co. , Ltd. is 90 days.
Which FDA product codes appear under Ashai Co. , Ltd.?
The most frequent FDA product codes under this applicant name are BYG (Mask, Oxygen, 4); BTI (Compressor, Air, Portable, 2); CAT (Cannula, Nasal, Oxygen, 2).
Next steps
- See all 12 Ashai Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BYG, Ashai Co. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.