# Terumo Cardiovascular Systems Corp.

- Location (FDA's records): Elkton, MD
- FDA decisions: 74 (2000–2024): 74 510(k) clearances
- Names in FDA's records: Terumo Cardiovascular Systems Corp. (43); Terumo Cardiovascular Systems Corporation (29); Terumo Cardiovascular Systems (2)
- Product codes: DTZ (12), DWF (10), DTQ (7), DTM (6), KFM (6), DTN (6), DRY (4), DTL (4), DWE (3), GCJ (3), DWB (3), GEI (2)
- 510(k) review time since 2016: median 175 days, against 98 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 99 (42 its own); citations of its devices by later devices: 62 (42 its own)
- Recalls linked to its devices: 262 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3M Health Care, Sarns: 13 (https://510kreport.com/company/3m-health-care-sarns)
- Terumo Medical Corp.: 11 (https://510kreport.com/company/terumo-medical)
- Terumo Corp.: 8 (https://510kreport.com/company/terumo)
- 3M Health Care, Ltd.: 4 (https://510kreport.com/company/3m-health-care)
- Medtronic Perfusion Systems: 3 (https://510kreport.com/company/medtronic-perfusion-systems)
- 3M Company: 2 (https://510kreport.com/company/3m)
- Guidant Corp.: 2 (https://510kreport.com/company/guidant)
- Medtronic Vascular: 2 (https://510kreport.com/company/medtronic-vascular)

## Firms that cite its devices most
- Terumo Corp.: 4 (https://510kreport.com/company/terumo)
- Sorin Group Deutschland GmbH: 3 (https://510kreport.com/company/sorin-group-deutschland)
- Maquet Cardiopulmonary, AG: 3 (https://510kreport.com/company/maquet-cardiopulmonary)
- Rand S.R.L.: 2 (https://510kreport.com/company/rand)
- Vortex Medical, Inc.: 2 (https://510kreport.com/company/vortex-medical)
- Medtronic, Inc.: 2 (https://510kreport.com/company/medtronic)
- Eurosets S.R.L: 1 (https://510kreport.com/company/eurosets)
- Orqis Medical Corporation: 1 (https://510kreport.com/company/orqis-medical)

## Its most-cited devices
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch (2003), cited by 6
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir (2005), cited by 5
- K083301: X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters (2008), cited by 3
- K041697: Terumo Circuit Connectors (2004), cited by 3
- K013578: Pump Tubing (2002), cited by 3
- K130359: Capiox SX18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox SX25 Hollow Fiber Oxgenator with Detacha (2013), cited by 2

## Recent decisions
- K234065: CDI OneView Monitoring System (Apr 25, 2024)
- K221895: Terumo Advanced Perfusion System 1 (Apr 18, 2023)
- K200091: Capiox iCP Centrifugal Pump (Nov 18, 2021)
- K182110: CDI Blood Parameter Monitoring System 550 (Nov 2, 2018)
- K180950: Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) (Jun 22, 2018)
- K172071: Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo  Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo  Capiox  NX19 Oxygenator (west orientation) (Mar 29, 2018)
- K172220: Advanced Perfusion System 1 (Aug 17, 2017)
- K163531: Advanced Perfusion System 1 (Jun 7, 2017)

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