# K971520: S3 Cyclic RPM Control

- Pathway: 510(k) (Traditional)
- Applicant: Stoeckert Instrumente
- Decided: Sep 10, 1997 after 138 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K883456: Stockert-Shiley CAPS PFC 100 S Control unit. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K042374: Stockert SCP Rhythm (2004), 6 descendants of its own
- K071318: Modification to: Stockert S5 System (2007), 5 descendants of its own
- K210130: Stockert S5 System (2021), 2 descendants of its own
- K112225: Sorin Centrifugal Pump 5 (CP5) (2011), 2 descendants of its own
- K082344: Stockert S5 System, Stockert Electrical Venous Occluder (Evo) (2008), 2 descendants of its own

## Indications for use
The Stockert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclic rpm control of an S3 pump.

Source page: https://510kreport.com/device/K971520
Methodology: https://510kreport.com/methodology