# K210130: Stockert S5 System

- Pathway: 510(k) (Special)
- Applicant: Livanova Deutschland, GmbH
- Decided: Apr 5, 2021 after 76 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
Longest line of descent: 3 generations back to K971520 (1997). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K221373: Essenz HLM (2023), 1 descendant of its own
- K232291: Essenz HLM, Essenz ILBM (2023), 0 descendants of its own

## 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/K210130
Methodology: https://510kreport.com/methodology