# K201984: MPS 3 ND Myocardial Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Nov 20, 2020 after 126 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K802147 (1980). 11 ancestors in all.
1 later device descends 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)
- K200438: MPS 3 Myocardial Protection System, Quest Medical, Inc. (2020) Summary page 5.

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

## Indications for use
The Quest MPS 3 ND Myocardial Protection System, consisting of the Quest MPS 3 ND Console, the Quest MPS 3 Controller, and the Quest MPS 3 ND Disposables (Quest MPS 3 ND Delivery Set and optional Accessories) 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/K201984
Methodology: https://510kreport.com/methodology