# K103762: Sorin C5 System; 85/C5 Mast Roller Pump System 150(1X RP 150 and Control Panel with Connecting Cables); S5/C5 Mast Rolle

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 20, 2011 after 28 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Stöckert S5 System: named in the summary without a submission number

## Indications for use
The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the C5 System. The 05 System has been qualified only for durations 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 head, or extracorporeal membrane oxygenation (ECMVO) procedures.

Source page: https://510kreport.com/device/K103762
Methodology: https://510kreport.com/methodology