Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
FDA 510(k) K250326 · Spectrum Medical S.R.L.
510(k) numberK250326
Submission
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- Applicant
- Spectrum Medical S.R.L.
Mirandola, IT - Received
- February 5, 2025
- Decision date
- June 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | Terumo Cardiovascular Systems Corporation | 11/18/2021SE |
| 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 |
|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR · Traditional | 03/12/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | 03/12/2026SE |
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | 08/04/2025SE |
| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | 07/18/2024SE |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF · Special | 05/31/2024SE |
Questions and answers
When was Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) cleared by the FDA?
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (K250326) received a 510(k) decision of Substantially Equivalent on June 24, 2025, 139 days after the submission was received.
What is the product code of K250326?
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.