# K953838: Myocardial Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Mar 6, 1996 after 203 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802147 (1980). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810079: Sarns Integrated Cardioplegia Deliv. Sys, 3M Health Care, Sarns (1981) Summary page 2.
- K923311: Conducer Heat Exchanger, 3M Health Care, Sarns (1992) Summary page 2.
- K904171: Scimed Cardiotherm Cardioplegia Delivery System, Scimed (1990) Summary page 2.
- K864619: Caps Low Level Detector & Detector/Bubble Monitor, Shiley, Inc. (1987) Summary page 2.
- K802147: Shiley Temperature Monitor, Shiley, Inc. (1980) Summary page 2.
- K862836: Stockert-Shiley Caps and Caps Dual Pressure Module, Shiley, Inc. (1986) Summary page 2.

## Most influential descendants
- 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
- K201984: MPS 3 ND Myocardial Protection System (2020), 1 descendant of its own

## Recalls of this device
- Oct 28, 2015 · Class II · Z-0361-2016: The products have been found to intermittently exhibit a seal failure during use.
- Jul 29, 2010 · Not classified · Z-1924-2011: User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
- May 23, 2003 · Not classified · Z-1037-03: Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

## Indications for use
The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery

Source page: https://510kreport.com/device/K953838
Methodology: https://510kreport.com/methodology