Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terumo Medical Corp. · Predicate Candidate Screening
143 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
204 days90th percentile
143clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Terumo Medical Corp. | 2011-10-03 | 116 | 1 |
| K111556 | GLIDECROSS SUPPORT CATHETER | Terumo Medical Corp. | 2011-07-29 | 53 | 0 |
| K110540 | TERUMO SUPPORT CATHETER | Terumo Medical Corp. | 2011-05-13 | 77 | 0 |
| K102008 | GLIDESHEATH | Terumo Medical Corp. | 2010-07-21 | 5 | 1 |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2009-05-29 | 24 | 1 |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Terumo Medical Corp. | 2009-04-15 | 189 | 0 |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Terumo Medical Corp. | 2009-02-06 | 31 | 0 |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Terumo Medical Corp. | 2008-10-29 | 30 | 0 |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Terumo Medical Corp. | 2008-09-26 | 24 | 0 |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Terumo Medical Corp. | 2008-09-24 | 6 | 0 |
| K082644 | GLIDESHEATH | Terumo Medical Corp. | 2008-09-18 | 7 | 0 |
| K082362 | SURSHIELD SAFETY I.V. CATHETER | Terumo Medical Corp. | 2008-09-17 | 30 | 0 |
| K081045 | DESTINATION RENAL GUIDING SHEATH | Terumo Medical Corp. | 2008-05-28 | 44 | 0 |
| K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2008-05-21 | 37 | 0 |
| K080563 | RUNTHROUGH NS EXTENSION WIRE | Terumo Medical Corp. | 2008-03-20 | 21 | 0 |
| K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDI | Terumo Medical Corp. | 2008-03-07 | 22 | 0 |
| K071630 | TERUMO 31G THINPRO INSULIN SYRINGE | Terumo Medical Corp. | 2007-07-11 | 27 | 0 |
| K063695 | RUNTHROUGH NS | Terumo Medical Corp. | 2007-04-27 | 135 | 1 |
| K070423 | TR BAND | Terumo Medical Corp. | 2007-03-28 | 43 | 0 |
| K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE | Terumo Medical Corp. | 2007-01-19 | 72 | 0 |
| K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2006-12-26 | 21 | 0 |
| K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | Terumo Medical Corp. | 2006-10-23 | 62 | 0 |
| K062858 | MODIFICATION TO GLIDESHEATH | Terumo Medical Corp. | 2006-10-20 | 25 | 0 |
| K060666 | CAROTID ACCESS KIT | Terumo Medical Corp. | 2006-06-29 | 107 | 0 |
| K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | Terumo Medical Corp. | 2005-09-27 | 78 | 0 |
| K052185 | DESTINATION CAROTID GUIDING SHEATH | Terumo Medical Corp. | 2005-09-06 | 26 | 1 |
| K052034 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2005-08-16 | 19 | 0 |
| K051601 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | Terumo Medical Corp. | 2005-08-04 | 49 | 0 |
| K040531 | TERUMO SURGUARD2 SAFETY NEEDLE | Terumo Medical Corp. | 2004-03-23 | 22 | 0 |
| K033913 | PROGREAT | Terumo Medical Corp. | 2004-03-11 | 85 | 0 |
| K033583 | PROGREAT | Terumo Medical Corp. | 2003-12-12 | 29 | 0 |
| K031453 | TERUMO SURGUARD 2 SAFETY NEEDLE | Terumo Medical Corp. | 2003-07-08 | 62 | 0 |
| K024249 | TERUMO SURGUARD SAFETY SYRINGE | Terumo Medical Corp. | 2003-02-21 | 60 | 0 |
| K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | Terumo Medical Corp. | 2002-12-18 | 78 | 0 |
| K012854 | RENAL GUIDING SHEATH | Terumo Medical Corp. | 2001-11-21 | 89 | 2 |
| K013550 | CLIRANS E-SERIES DIALYZER | Terumo Medical Corp. | 2001-11-20 | 27 | 0 |
| K012812 | CAROTID GUIDING SHEATH | Terumo Medical Corp. | 2001-11-14 | 84 | 1 |
| K013164 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET | Terumo Medical Corp. | 2001-10-15 | 24 | 0 |
| K012646 | TERUMO 30 GAUGE HYPODERMIC NEEDLE | Terumo Medical Corp. | 2001-08-27 | 14 | 0 |
| K010103 | SURSHIELD WINGED INFUSION SET | Terumo Medical Corp. | 2001-03-15 | 62 | 0 |
| K003571 | SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ | Terumo Medical Corp. | 2001-02-12 | 84 | 0 |
| K003425 | CLIRANS E-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 2001-02-01 | 90 | 2 |
| K003424 | PINNACLE R/O II OR RADIFOCUS INTRODUCER II | Terumo Medical Corp. | 2000-11-21 | 18 | 0 |
| K002026 | CAPIOX ARTERIAL FILTER | Terumo Medical Corp. | 2000-09-06 | 65 | 0 |
| K001474 | TERUMO U-100 INSULIN SYRING | Terumo Medical Corp. | 2000-06-09 | 29 | 0 |
| K993772 | X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ | Terumo Medical Corp. | 2000-06-05 | 210 | 1 |
| K000387 | TERUMO NEEDLE WITH LOCKING SHEATH | Terumo Medical Corp. | 2000-03-02 | 24 | 0 |
| K992802 | TERUMO U-100 INSULIN SYRINGE | Terumo Medical Corp. | 1999-09-09 | 21 | 0 |
| K991973 | CAPIOX SX10 HARDSHELL RESEVOIR | Terumo Medical Corp. | 1999-09-03 | 84 | 0 |
| K992051 | RADIFOCUS OPTITORQUE | Terumo Medical Corp. | 1999-08-10 | 53 | 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