Capiox iCP Centrifugal Pump
FDA 510(k) K200091 · Terumo Cardiovascular Systems Corporation
510(k) numberK200091
Submission
- Device name
- Capiox iCP Centrifugal Pump
- Applicant
- Terumo Cardiovascular Systems Corporation
Ann Arbor, MI, US - Received
- January 16, 2020
- Decision date
- November 18, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4360
- Specialty
- Cardiovascular
Other 510(k)s with product code KFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 08/04/2025SE |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 06/24/2025SE |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…KFM · Special | Qura S.R.L | 10/26/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | Cardiacassist, Inc. | 08/03/2023SE |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…KFM · Traditional | Qura S.R.L | 05/19/2023SE |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorKFM · Traditional | Qura S.R.L | 11/03/2021SE |
| K193663 | FloPump 57mL Centrifugal PumpKFM · Traditional | International Biophysics Corporation | 03/10/2021SE |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM · Special | Qura S.R.L | 09/02/2020SE |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance…KFM · Special | Medtronic, Inc. | 05/21/2020SE |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM · Traditional | Qura S.R.L | 04/13/2020SE |
More from Qura S.R.L
| 510(k) | Device | Decision |
|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | 04/25/2024SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | 04/18/2023SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | 11/02/2018SE |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional | 06/22/2018SE |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19…DTZ · Traditional | 03/29/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | 06/07/2017SE |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | 11/17/2016SE |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional | 04/21/2016SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | 12/16/2015SE |
Questions and answers
When was Capiox iCP Centrifugal Pump cleared by the FDA?
Capiox iCP Centrifugal Pump (K200091) received a 510(k) decision of Substantially Equivalent on November 18, 2021, 672 days after the submission was received.
What is the product code of K200091?
The FDA product code is KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4360.