# K041979: MPS Myocardial Protection System - MPS 2 Console, Model 5201260

- Pathway: 510(k) (Special)
- Applicant: Quest Medical, Inc.
- Decided: Sep 2, 2004 after 41 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- 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: 3 generations back to K802147 (1980). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994274: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab), Quest Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K240908: Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (2025), 0 descendants of its own

## Recalls of this device
- Jul 29, 2010 · Not classified · Z-1924-2011: User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

## Indications for use
The Quest Medical MPS® 2 Myocardial Protection System, consisting of the MPS 2 Console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and / or cardioplegia solutions to the head during open heart surgery on either an arrested or beating heart for use up to six hours in duration

Source page: https://510kreport.com/device/K041979
Methodology: https://510kreport.com/methodology