Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Yamaha Motor Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026-03-19 | 259 | 0 |
| K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | 2021-05-21 | 144 | 0 |
| K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014-08-28 | 213 | 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