# K192838: Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Apr 13, 2020 after 193 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991864 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011838: Centrifugal Pump, Stockert Instrumente GmbH (2002) Summary page 4.

## Indications for use
The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum Pureflow Centrifugal Blood Pump for speed-controlled pumping through the extracorporeal circuit for typical durations of six hours or less.

Source page: https://510kreport.com/device/K192838
Methodology: https://510kreport.com/methodology