# Terumo Medical Corp.

- Location (FDA's records): Elkton, MD
- FDA decisions: 160 (1980–2023): 157 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Terumo Medical Corp. (143); Terumo Medical Corporation (17)
- Product codes: DYB (27), DQX (11), FMF (10), DTZ (10), DQO (6), FPA (6), FJI (6), FOZ (5), DQY (4), FMI (4), DTN (4), KOC (4)
- 510(k) review time since 2016: median 85 days, against 70 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 108 (66 its own); citations of its devices by later devices: 242 (66 its own)
- Recalls linked to its devices: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terumo America, Inc.: 8 (https://510kreport.com/company/terumo-america)
- Terumo Corp.: 5 (https://510kreport.com/company/terumo)
- Spectranetics Corp.: 3 (https://510kreport.com/company/spectranetics)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 3 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Becton Dickinson Vascular Access, Inc.: 2 (https://510kreport.com/company/becton-dickinson-vascular-access)
- Arrow Intl., Inc.: 2 (https://510kreport.com/company/arrow-intl)
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)

## Firms that cite its devices most
- Terumo Corp.: 14 (https://510kreport.com/company/terumo)
- Terumo Cardiovascular Systems Corp.: 11 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Terumo Europe N.V.: 8 (https://510kreport.com/company/terumo-europe)
- Cook, Inc.: 6 (https://510kreport.com/company/cook)
- Merit Medical Systems, Inc.: 5 (https://510kreport.com/company/merit-medical-systems)
- Medtronic Vascular: 5 (https://510kreport.com/company/medtronic-vascular)
- Ashitaka Factory of Terumo Corp.: 4 (https://510kreport.com/company/ashitaka-factory-of-terumo)
- Smiths Medical Asd, Inc.: 4 (https://510kreport.com/company/smiths-medical-asd)

## Its most-cited devices
- K863138: Terumo Radifocus Guide Wire (1986), cited by 12
- K070423: TR Band (2007), cited by 11
- K082644: Glidesheath (2008), cited by 9
- K091329: Pinnacle Destination Peripheral Guiding Sheath (2009), cited by 8
- K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter (1999), cited by 6
- K033583: Progreat (2003), cited by 6

## Recent decisions
- P210017: Cross-Seal Suture-Mediated Vascular Closure Device System (Sep 26, 2023)
- K231044: R2P Navicross (Jul 27, 2023)
- K213531: TR BAND Radial Compression Device (Dec 20, 2021)
- K193125: R2P Destination Slender Guiding Sheath (Jan 6, 2020)
- K181237: Glidesheath Slender Tibial Pedal Kit (Aug 3, 2018)
- K173831: Glidesheath Slender (May 8, 2018)
- K172995: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (Nov 21, 2017)
- K171491: R2P Destination Slender Guiding Sheath (Oct 5, 2017)

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