# K960916: Sams 8000 Cardioplegia Monitor

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Jun 4, 1996 after 90 days
- Product code: DSJ (Alarm, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871131 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915183: Sarns 8000 Modular Perfusion System, 3M Health Care, Sarns (1992) Summary page 1.
- K871131: Sarns 9000 Heart-Lung Console, 3M Health Care, Sarns (1987) Summary page 1.

## Recalls of this device
- Aug 29, 2011 · Not classified · Z-3214-2011: The Cardioplegia Monitor for the Sarns Modular Perfusion System 8000 may fail to track cardioplegia delivery volume.

## Indications for use
The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit, either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardioplegia doses, and tracks the volume of cardioplegia delivered.

Source page: https://510kreport.com/device/K960916
Methodology: https://510kreport.com/methodology