Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mochida Pharmaceutical 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) |
|---|---|---|---|---|---|
| K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 | 266 | 0 |
| K852122 | MEDILASER MIC MODEL MEL-445C, 15W | Mochida Pharmaceutical Co., Ltd. | 1985-08-20 | 97 | 0 |
| K852121 | MEDILASER MIC MODEL MEL 440-C;30W | Mochida Pharmaceutical Co., Ltd. | 1985-08-20 | 97 | 0 |
| K840739 | MEDILASER-S MEL-444-S | Mochida Pharmaceutical Co., Ltd. | 1984-09-20 | 212 | 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