Terumo Corp.
Shibuya-Ku, Tokyo, JP
TERUMO CORP. appears in FDA device records in Shibuya-Ku, Tokyo, JP. FDA records list 34 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 34 510(k) clearances for Terumo Corp. between 1991 and 2026. The busiest year on record is 2003, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1995 | 1 |
| 1998 | 2 |
| 2000 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 2 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252295 | Ryurei | LOX | Substantially Equivalent | |
| K250700 | Pen Injector Needle 32.5 | FMI | Substantially Equivalent | |
| K250751 | DualView Catheter | DQO | Substantially Equivalent | |
| K240818 | R2P Radifocus Glidewire Advantage | DQX | Substantially Equivalent | |
| K240859 | Glidewire GT-R | DQX | Substantially Equivalent | |
| K190427 | Immucise | FMF | Substantially Equivalent | |
| K181369 | Immucise Intradermal Injection System | FMI | Substantially Equivalent | |
| K173799 | NaviCross 0.018 | DQY | Substantially Equivalent | |
| K170417 | Glidewire GT | DQX | Substantially Equivalent | |
| K130493 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | Substantially Equivalent | |
| K130280 | CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR | DTZ | Substantially Equivalent | |
| K122544 | TERUMO SURFLASH SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | |
| K113335 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | |
| K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | |
| K092372 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | |
| K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | OCY | Substantially Equivalent | |
| K090973 | TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) | FOZ | Substantially Equivalent | |
| K073474 | CAPIOX CIRCUIT CONNECTORS | DTL | Substantially Equivalent | |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | DTZ | Substantially Equivalent | |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | DTZ | Substantially Equivalent | |
| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | DXN | Substantially Equivalent | |
| K040783 | FOUNDATION | LYC | Substantially Equivalent | |
| K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | |
| K033681 | GLIDESHEATH | DYB | Substantially Equivalent | |
| K031266 | SURSHIELD SAFETY WINGED INFUSION SET | FPA | Substantially Equivalent | |
| K030449 | MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR | DTN | Substantially Equivalent | |
| K022115 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | |
| K003371 | PUMP TUBING WITH X-COATING | DWF | Substantially Equivalent | |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | DWE | Substantially Equivalent | |
| K983490 | TERUMO VENOJECT,LUER ADAPTER | JKA | Substantially Equivalent | |
| K980796 | TERUMO ALLERGY SYRINGE | FMF | Substantially Equivalent | |
| K943861 | CAPIOX SP PUMP HEAD | KFM | Substantially Equivalent | |
| K910969 | TORQUE DEVICE FOR A GUIDE WIRE | DQX | Substantially Equivalent | |
| K910722 | 450CM GUIDE WIRE FOR G.I. USE | OCY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010026 | 2828 | TERUMO CORP. | 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072 JP | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LYCBone Grafting Material, Synthetic
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- OBJCatheter, Ultrasound, Intravascular
- KODCatheter, Urological
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DXCClamp, Vascular
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- FLLContinuous Measurement Thermometer
- KRLDetector, Bubble, Cardiopulmonary Bypass
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- FMINeedle, Hypodermic, Single Lumen
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- KSBSet, Transfer (Blood/Plasma)
- NIOStent, Iliac
- NIPStent, Superficial Femoral Artery
- KSSSupplies, Blood-Bank
- FMFSyringe, Piston
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- DWETubing, Pump, Cardiopulmonary Bypass
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain