Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumo (Philippines) Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
230 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | Terumo (Philippines) Corporation | 2015-10-16 | 57 | 0 |
| K133280 | TERUMO SURFLO I.V. CATHETER | Terumo (Philippines) Corporation | 2014-06-12 | 230 | 0 |
| K121607 | TERUMO(R) NEEDLE | Terumo (Philippines) Corporation | 2012-11-08 | 160 | 0 |
| K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAF | Terumo (Philippines) Corporation | 2012-08-28 | 32 | 0 |
| K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC | Terumo (Philippines) Corporation | 2012-03-05 | 105 | 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