# K011838: Centrifugal Pump

- Pathway: 510(k) (Traditional)
- Applicant: Stockert Instrumente GmbH
- Decided: Feb 5, 2002 after 238 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991864 (2000). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 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) Summary page 1.
- (no number) Medtronic Bio-Medicus BioConsole 540/550: named in the summary without a submission number

## Most influential descendants
- K021694: Cardiovention Powerbase Console, Model PBC-100 (2003), 1 descendant of its own
- K192838: Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (2020), 0 descendants of its own
- K032213: Stockert Centrifugal Pump System with Tubing Clamp (2003), 0 descendants of its own
- K030141: Modification to Cardiovention Powerbase Console, Model PCB-100 (2003), 0 descendants of its own

## Recalls of this device
- Aug 26, 2019 · Class II · Z-2440-2020: The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a resu
- Aug 26, 2019 · Class II · Z-2439-2020: The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a resu
- Sep 20, 2012 · Class II · Z-0166-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board compon
- Sep 20, 2012 · Class II · Z-0167-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board compon

## Indications for use
The Stéckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP has been qualified only for typical durations of six hours or less, 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 heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Source page: https://510kreport.com/device/K011838
Methodology: https://510kreport.com/methodology