# K250326: Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical S.R.L.
- Decided: Jun 24, 2025 after 139 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: 7 generations back to K922933 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201320: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor, Qura S.R.L (2021) Summary page 5.

## Indications for use
The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure 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. Device is intended for adult patients.

Source page: https://510kreport.com/device/K250326
Methodology: https://510kreport.com/methodology