Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ashitaka Factory of Terumo Corp. · 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) |
|---|---|---|---|---|---|
| K152740 | Radifocus Glidewire | Ashitaka Factory of Terumo Corp. | 2015-11-16 | 54 | 0 |
| K150232 | Radifocus Optitorque Angiographic Catheter | Ashitaka Factory of Terumo Corp. | 2015-10-19 | 259 | 0 |
| K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | Ashitaka Factory of Terumo Corp. | 2013-03-13 | 13 | 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