# K060053: Stockert S5 System

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jun 2, 2006 after 147 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
1 of 4 devices in its family (counting itself) has 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 S3 System: named in the summary without a submission number

## Most influential descendants
- K202125: Century Perfusion System (2021), 0 descendants of its own
- K190282: Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (2019), 0 descendants of its own
- K173834: Quantum Pump Console (2018), 0 descendants of its own

## Recalls of this device
- Feb 16, 2012 · Not classified · Z-1149-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1155-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1151-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1158-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1157-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1152-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1153-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1150-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1154-2012: Touch screen may be unresponsive, inhibiting user input.
- Feb 16, 2012 · Not classified · Z-1156-2012: Touch screen may be unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0965-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0957-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0958-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0963-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0964-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0956-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0959-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0960-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0962-2011: Touch screen may become unresponsive, inhibiting user input.
- Nov 12, 2010 · Not classified · Z-0961-2011: Touch screen may become unresponsive, inhibiting user input.

## Indications for use
The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Source page: https://510kreport.com/device/K060053
Methodology: https://510kreport.com/methodology