Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kofu Factory of Terumo Corp. · 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) |
|---|---|---|---|---|---|
| K140516 | Terumo Pen Injector Needle 34 | Kofu Factory of Terumo Corp. | 2014-08-05 | 158 | 0 |
| K141138 | SURFLASH SAFETY I.V. CATHETER | Kofu Factory of Terumo Corp. | 2014-05-30 | 28 | 0 |
| K123267 | SURFFLASH(R) PLUS SAFETY I.V. CATHETER | Kofu Factory of Terumo Corp. | 2012-11-02 | 14 | 0 |
| K052561 | TERUMO MICRO TAPERED PEN NEEDLE | Kofu Factory of Terumo Corp. | 2005-11-23 | 65 | 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