# K032213: Stockert Centrifugal Pump System with Tubing Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Stockert Instrumente GmbH
- Decided: Aug 29, 2003 after 39 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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)
- K961364: Automatic Tubing Clamp System (Atc), Rocky Mountain Research, Inc. (1996) Summary page 1.

## Indications for use
The Stockert Centrihgal Pump System with Tubing Clamp (SCP System TC) is a cardiopulmonary bypass speed control device that is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP System TC 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. The SCP System TC controls a Tubing Clamp that is positioned at the pump outlet to occlude the arterial line if the reservoir blood level, microbubble activity, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure.

Source page: https://510kreport.com/device/K032213
Methodology: https://510kreport.com/methodology