Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ashai Co. , Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
133 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870428 | AEROSOL ONE, NEBULIZER PUMP | Ashai Co. , Ltd. | 1987-05-15 | 101 | 0 |
| K852622 | AEROSOL ONE | Ashai Co. , Ltd. | 1986-04-24 | 308 | 0 |
| K852620 | SAFE.N.SURE | Ashai Co. , Ltd. | 1985-10-31 | 133 | 0 |
| K852627 | MAXI-NEB | Ashai Co. , Ltd. | 1985-09-26 | 98 | 0 |
| K852624 | OXY-TWO | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852618 | OXY-DIAL | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852628 | NASAL ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852629 | AERO-MASK TWO | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852623 | OXY-ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852626 | AERO-MASK ONE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852625 | OXY-TUBE | Ashai Co. , Ltd. | 1985-09-18 | 90 | 0 |
| K852619 | URI-SURE | Ashai Co. , Ltd. | 1985-08-27 | 68 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda