# K093882: Sorin C5 System Model 58-00-00

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 15, 2010 after 28 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 7 (0 Class I)
- 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) Stockert S5 System: named in the summary without a submission number

## Recalls of this device
- Dec 4, 2013 · Class II · Z-0856-2014: 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.
- Sep 19, 2012 · Class II · Z-0274-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message dis
- Sep 19, 2012 · Class II · Z-0275-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message dis
- Sep 19, 2012 · Class II · Z-0272-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message dis
- Sep 19, 2012 · Class II · Z-0271-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message dis
- Sep 19, 2012 · Class II · Z-0273-2013: Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message dis
- Feb 23, 2012 · Not classified · Z-1330-2012: 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 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 CE System.

Source page: https://510kreport.com/device/K093882
Methodology: https://510kreport.com/methodology