Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumo Corporation · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
247 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252295 | Ryurei | Terumo Corporation | 2026-03-27 | 247 | 0 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 | 259 | 0 |
| K250751 | DualView Catheter | Terumo Corporation | 2025-07-17 | 127 | 0 |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corporation | 2024-11-26 | 246 | 0 |
| K240859 | Glidewire GT-R | Terumo Corporation | 2024-08-21 | 146 | 0 |
| K190427 | Immucise | Terumo Corporation | 2019-07-18 | 146 | 0 |
| K181369 | Immucise Intradermal Injection System | Terumo Corporation | 2018-11-13 | 174 | 0 |
| K173799 | NaviCross 0.018 | Terumo Corporation | 2018-03-29 | 105 | 0 |
| K170417 | Glidewire GT | Terumo Corporation | 2017-09-15 | 217 | 0 |
| K130280 | CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR | Terumo Corporation | 2013-03-13 | 36 | 0 |
| K130493 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR | Terumo Corporation | 2013-03-13 | 15 | 0 |
| K122544 | TERUMO SURFLASH SAFETY I.V. CATHETER | Terumo Corporation | 2012-09-05 | 15 | 0 |
| K113335 | HEARTRAIL III GUIDING CATHETER | Terumo Corporation | 2012-07-16 | 245 | 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