Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Terumo Medical Products (Hangzhou) Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
403 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-18 | 140 | 0 |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 | 139 | 0 |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | 2023-06-23 | 403 | 0 |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-06-29 | 90 | 0 |
| K031279 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET | Terumo Medical Products Hangzhou Co., Ltd. | 2003-05-30 | 38 | 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