# K091007: Air Purge Control System for S5 System Model 23-45-05

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jul 2, 2009 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K103469: Stockert Air Purge Control System Model 23-45-05 (2011), 0 descendants of its own

## Indications for use
The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit. The Synergy/ECC.Q shall only be used in conjunction with the Stöckert S5 System and SCP Plus (Stöckert Centrifugal Pump Plus) System and the S5 System. The Stockert S5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.

Source page: https://510kreport.com/device/K091007
Methodology: https://510kreport.com/methodology