# K112225: Sorin Centrifugal Pump 5 (CP5)

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Sep 20, 2011 after 48 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: 3 generations back to K971520 (1997). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103468: Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems), Sorin Group Deutschland GmbH (2011) Summary page 1.
- K071318: Modification to: Stockert S5 System, Sorin Group Deutschland GmbH (2007) Summary page 1.

## Most influential descendants
- K221373: Essenz HLM (2023), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## Recalls of this device
- Dec 17, 2021 · Class III · Z-0787-2022: One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- Oct 30, 2017 · Class II · Z-0401-2018: Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended by design in the CP5 system.
- Dec 4, 2013 · Class II · Z-0857-2014: Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting in no response.
- Feb 23, 2012 · Not classified · Z-1329-2012: The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult t

## Indications for use
The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®5, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The 0P5 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 (ECMVO) procedures.

Source page: https://510kreport.com/device/K112225
Methodology: https://510kreport.com/methodology