# Terumo Corp.

- Location (FDA's records): Elkton, MD
- FDA decisions: 34 (1991–2026): 34 510(k) clearances
- Names in FDA's records: Terumo Corp. (21); Terumo Corporation (13)
- Product codes: DTZ (6), DQX (4), DQO (3), FOZ (3), FMI (2), OCY (2), FMF (2), LYC (1), LOX (1), DXN (1), KFM (1), DTN (1)
- 510(k) review time since 2016: median 196 days, against 138 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 44 (9 its own); citations of its devices by later devices: 46 (9 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo Medical Corp.: 14 (https://510kreport.com/company/terumo-medical)
- Terumo Cardiovascular Systems Corp.: 4 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Becton Dickinson Vascular Access, Inc.: 2 (https://510kreport.com/company/becton-dickinson-vascular-access)
- Geistlich Pharma AG: 1 (https://510kreport.com/company/geistlich-pharma)
- Kofu Factory of Terumo Corp.: 1 (https://510kreport.com/company/kofu-factory-of-terumo)
- Ashitaka Factory of Terumo Corp.: 1 (https://510kreport.com/company/ashitaka-factory-of-terumo)
- Olympus Optical Co., Ltd.: 1 (https://510kreport.com/company/olympus-optical)

## Firms that cite its devices most
- Terumo Cardiovascular Systems Corp.: 8 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Terumo Medical Corp.: 5 (https://510kreport.com/company/terumo-medical)
- Terumo Europe N.V.: 3 (https://510kreport.com/company/terumo-europe)
- Maquet Cardiopulmonary, AG: 2 (https://510kreport.com/company/maquet-cardiopulmonary)
- Kofu Factory of Terumo Corp.: 2 (https://510kreport.com/company/kofu-factory-of-terumo)
- Gish Biomedical, Inc.: 2 (https://510kreport.com/company/gish-biomedical)
- Nanopass Technologies, Ltd.: 1 (https://510kreport.com/company/nanopass-technologies)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Its most-cited devices
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir (2002), cited by 8
- K910969: Torque Device for a Guide Wire (1991), cited by 4
- K040783: Foundation (2004), cited by 3
- K980796: Terumo Allergy Syringe (1998), cited by 3
- K983490: Terumo Venoject,Luer Adapter (1998), cited by 3
- K040210: Capiox RX25 Hollow Fiber Oxygenator W/WO Hardshell Reservoir (2004), cited by 3

## Recent decisions
- K252295: Ryurei (Mar 27, 2026)
- K250700: Pen Injector Needle 32.5 (Nov 21, 2025)
- K250751: DualView Catheter (Jul 17, 2025)
- K240818: R2P Radifocus Glidewire Advantage (Nov 26, 2024)
- K240859: Glidewire GT-R (Aug 21, 2024)
- K190427: Immucise (Jul 18, 2019)
- K181369: Immucise Intradermal Injection System (Nov 13, 2018)
- K173799: NaviCross 0.018 (Mar 29, 2018)

Source page: https://510kreport.com/company/terumo