# K091008: Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jul 15, 2009 after 97 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
No predicates in its family tree.
4 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)
- None. The FDA summary names its predicate without a number.
- (no number) Stockert Centrifugal Pump System: named in the summary without a submission number

## Most influential descendants
- K103468: Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems) (2011), 3 descendants of its own
- 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 Plus System (SCP Plus) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) that is indicated for use with the COBE Revolution Pump Head/Dideco Synergy/ECC.O for speed-controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended to be used with the S3 or S5 System and the Stbckert 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/K091008
Methodology: https://510kreport.com/methodology