# K103468: Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 20, 2011 after 57 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: 1 generation back to K091008 (2009). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091008: Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55, Sorin Group Deutschland GmbH (2009) Summary page 1.

## Most influential descendants
- K112225: Sorin Centrifugal Pump 5 (CP5) (2011), 2 descendants of its own
- K221373: Essenz HLM (2023), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Indications for use
The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy T/ECC.OT for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware versions of 3.0. or greater) and the Stockert Air Purge Control (APC) System. The SCP Plus 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/K103468
Methodology: https://510kreport.com/methodology