# K062396: Modification to Stockert S5 System

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Sep 28, 2006 after 43 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) Stöckert S5 System: named in the summary without a submission number

## Most influential descendants
- K071318: Modification to: Stockert S5 System (2007), 5 descendants of its own
- K210130: Stockert S5 System (2021), 2 descendants of its own
- K112225: Sorin Centrifugal Pump 5 (CP5) (2011), 2 descendants of its own
- K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo) (2008), 2 descendants of its own
- K221373: Essenz HLM (2023), 1 descendant of its own

## Recalls of this device
- Jun 18, 2010 · Not classified · Z-2073-2010: Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder

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

Source page: https://510kreport.com/device/K062396
Methodology: https://510kreport.com/methodology