Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Terumo Medical Corporation · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
141 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231044 | R2P Navicross | Terumo Medical Corporation | 2023-07-27 | 106 | 0 |
| K213531 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2021-12-20 | 45 | 0 |
| K193125 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2020-01-06 | 55 | 0 |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corporation | 2018-08-03 | 85 | 0 |
| K173831 | Glidesheath Slender | Terumo Medical Corporation | 2018-05-08 | 141 | 1 |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral G | Terumo Medical Corporation | 2017-11-21 | 55 | 0 |
| K171491 | R2P Destination Slender Guiding Sheath | Terumo Medical Corporation | 2017-10-05 | 136 | 0 |
| K152173 | Glidesheath | Terumo Medical Corporation | 2015-12-01 | 119 | 0 |
| K152525 | TR BAND Radial Compression Device | Terumo Medical Corporation | 2015-11-10 | 68 | 0 |
| K151471 | Radifocus Glidewire Endoscopic Wire | Terumo Medical Corporation | 2015-09-17 | 108 | 0 |
| K142183 | GLIDESHEATH SLENDER | Terumo Medical Corporation | 2014-11-21 | 105 | 0 |
| K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE | Terumo Medical Corporation | 2013-03-01 | 189 | 0 |
| K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER | Terumo Medical Corporation | 2012-12-11 | 76 | 0 |
| K112382 | TERUMO ASPRIATION CATHETER | Terumo Medical Corporation | 2011-12-14 | 118 | 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