# K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo)

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Dec 17, 2008 after 124 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915183 (1992). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071318: Modification to: Stockert S5 System, Sorin Group Deutschland GmbH (2007) Summary page 1.
- K022947: Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 Inch, Terumo Cardiovascular Systems Corp. (2003) 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
- Jun 18, 2010 · Not classified · Z-2075-2010: 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 modified St6ckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.

Source page: https://510kreport.com/device/K082344
Methodology: https://510kreport.com/methodology