# K982014: Stockert Compact System

- Pathway: 510(k) (Special)
- Applicant: Stoeckert Instrumente
- Decided: Sep 4, 1998 after 88 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.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Stockert S3 System Modules: named in the summary without a submission number

## Most influential descendants
- K020571: Stockert Centrifugal Pump Console (2002), 0 descendants of its own
- K992635: Interface Module Iddd (1999), 0 descendants of its own

## Indications for use
The SC System is an integratea heart lung machine consisting of pumps and monitoring and control elements on a single chassis. It is indicated for speed controlled pumping througl-x the cardiopulmonaxy Lypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used l)y a qualified perfusionist who is experienced in the operation of the SC System. The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified throug}x in vitro, in vivo, or clinical studies, for long term use as a briclge to transplant, pencling recovery of the natural heart, or ex’cracorporeal membrane oxygenation (ECMO) procedures.

Source page: https://510kreport.com/device/K982014
Methodology: https://510kreport.com/methodology