# K202169: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

- Pathway: 510(k) (Special)
- Applicant: Qura S.R.L
- Decided: Sep 2, 2020 after 30 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922933 (1992). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192850: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22, Qura S.R.L (2020) Summary page 5.

## Most influential descendants
- K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (2021), 2 descendants of its own
- K250326: Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (2025), 0 descendants of its own
- K233091: Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) (2023), 0 descendants of its own

## Indications for use
The Quantum PureFlow Centrifugal Blood Pump CP22 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. The Quantum PureFlow Centrifugal Blood Pump CP37 indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K202169
Methodology: https://510kreport.com/methodology