Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anzai Medical Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2017-04-05 | 27 | 0 |
| K160432 | Anzai Respiratory Gating System | Anzai Medical Co., Ltd. | 2016-04-22 | 66 | 0 |
| K031385 | ANZAI AZ-733 RESPIRATORY GATING SYSTEM | Anzai Medical Co., Ltd. | 2003-11-10 | 193 | 0 |
| K022342 | EZ-SCOPE AN, EZ-SCOPE LIGHT | Anzai Medical Co., Ltd. | 2002-10-09 | 83 | 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