# K972321: S3 Mast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Stoeckert Instrumente
- Decided: Feb 27, 1998 after 249 days
- Product code: DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4370
- 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 K955038 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955038: Stockert S3 Double Head Pump Module, Stoeckert Instrumente (1996) Summary page 1.

## Indications for use
The Stockert S3 Mast Pump is a modular component of the Stickert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.

Source page: https://510kreport.com/device/K972321
Methodology: https://510kreport.com/methodology