# K041558: Stockertir Purge Control (Apc) System

- Pathway: 510(k) (Special)
- Applicant: Stockert Instrumente GmbH
- Decided: Jul 2, 2004 after 22 days
- Product code: DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955152 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955152: Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. CTRL., Temp Mont., Timer, Stoeckert Instrumente (1996) Summary page 1.

## Most influential descendants
- K103469: Stockert Air Purge Control System Model 23-45-05 (2011), 0 descendants of its own

## Indications for use
The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 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, when used by a qualified perfusionist who is experienced in the operation of the S3 System.

Source page: https://510kreport.com/device/K041558
Methodology: https://510kreport.com/methodology