# K020571: Stockert Centrifugal Pump Console

- Pathway: 510(k) (Traditional)
- Applicant: Stockert Instrumente GmbH
- Decided: Sep 23, 2002 after 214 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- 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 K920077 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991864: Rotaflow Centrifugal Pump System, Jostra Medizintechnik AG (2000)
- K972740: Himex Centriflow Centrifugal Perfusion Pump System (CFK01), Himex Production Corp. (1998) Summary page 1.
- K982014: Stockert Compact System, Stoeckert Instrumente (1998) Summary page 1.
- (no number) Medtronic Bio-Console 540/550: named in the summary without a submission number

## Indications for use
The Stockert Centrifugal Pump Console (SCPC System) is a sofhvare-controlled cardiopulmonary bypass device containing an unintermptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stockert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural head, or extracorporeal membrane oxygenation (ECMO) procedures.

Source page: https://510kreport.com/device/K020571
Methodology: https://510kreport.com/methodology