# K103469: Stockert Air Purge Control System Model 23-45-05

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Deutschland GmbH
- Decided: Jan 18, 2011 after 55 days
- Product code: KRL (Detector, Bubble, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4205
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955152 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091007: Air Purge Control System for S5 System Model 23-45-05, Sorin Group Deutschland GmbH (2009) Summary page 1.
- K041558: Stockertir Purge Control (Apc) System, Stockert Instrumente GmbH (2004) Summary page 1.

## Indications for use
The Stbckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the SynergyTM/ECC. OTM System tubing circuit. The Synergy TM/ECCO TM shall only be used in conjunction with the Stdckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCIP Plus System. The Stbckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution

Source page: https://510kreport.com/device/K103469
Methodology: https://510kreport.com/methodology