# K241206: Quantum Perfusion Hybrid System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical S.R.L.
- Decided: Jul 18, 2024 after 79 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922933 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 5.

## Indications for use
The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

Source page: https://510kreport.com/device/K241206
Methodology: https://510kreport.com/methodology