Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
FDA 510(k) K220842 · Qura S.R.L
510(k) numberK220842
Submission
- Device name
- Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
- Applicant
- Qura S.R.L
Mirandola, IT - Received
- March 23, 2022
- Decision date
- May 19, 2023
- 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 |
| 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 |
| 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 |
|---|---|---|
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | 09/12/2024SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | 11/08/2023SE |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…KFM · Special | 10/26/2023SE |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F…DWF · Special | 08/18/2022SE |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetDWF · Traditional | 05/20/2022SE |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | 05/06/2022SE |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum…DTZ · Traditional | 01/28/2022SE |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerDTR · Traditional | 01/10/2022SE |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC…DTZ · Traditional | 12/17/2021SE |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F…DWF · Traditional | 11/08/2021SE |
Questions and answers
When was Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors cleared by the FDA?
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842) received a 510(k) decision of Substantially Equivalent on May 19, 2023, 422 days after the submission was received.
What is the product code of K220842?
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.