# K810079: Sarns Integrated Cardioplegia Deliv. Sys

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Jan 30, 1981 after 17 days
- Product code: KRI (Accessory Equipment, Cardiopulmonary Bypass)
- Device class: 1
- Regulation: 21 CFR 870.4200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K953838: Myocardial Protection System (1996), 7 descendants of its own
- K994274: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab) (2000), 5 descendants of its own
- K041979: MPS Myocardial Protection System - MPS 2 Console, Model 5201260 (2004), 4 descendants of its own
- K173716: MPS2 Myocardial Protection System Console (2018), 3 descendants of its own
- K200438: MPS 3 Myocardial Protection System (2020), 2 descendants of its own

## Recalls of this device
- Mar 1, 2011 · Class II · Z-0157-2015: Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

Source page: https://510kreport.com/device/K810079
Methodology: https://510kreport.com/methodology