# K173716: MPS2 Myocardial Protection System Console

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Oct 1, 2018 after 300 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: 4 generations back to K802147 (1980). 9 ancestors in all.
3 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)
- K041979: MPS Myocardial Protection System - MPS 2 Console, Model 5201260, Quest Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- 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
- Dec 17, 2019 · Class II · Z-2107-2020: Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood t

## Indications for use
The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 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 heart 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/K173716
Methodology: https://510kreport.com/methodology