# K101046: Stockert S5 System and Gas Blender and Sorin C5 System

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Dec 9, 2010 after 239 days
- Product code: DTX (Gas Control Unit, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4300
- 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 K802226 (1980). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023745: Sechrist Air/Oxygen Mixer, Model 3500 CP-G, Sechrist Industries, Inc. (2003) Summary page 1.

## Most influential descendants
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K202733: Quantum Ventilation Module (2020), 1 descendant of its own
- K210669: Quantum Mini Ventilation Module (2021), 0 descendants of its own

## Indications for use
The Stöckert Gas Blenders (2L, 5L, and 10L) are intended to enable qualified personnel to set monitor and control gas flows of medical grade gases (air/O2/CO2) during cardiopulmonary bypass. The Stockert Gas Blenders are used as components of or optional accessories to the Stöckert S5 System (or any compatible Sorin system using the S5 firmware versions of 3.0 or greater) for periods of six hours or less.

Source page: https://510kreport.com/device/K101046
Methodology: https://510kreport.com/methodology