# K994274: Quest MPS Perfusion Assisted Direct Coronary Artery Bypass (Padcab)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: May 31, 2000 after 163 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K802147 (1980). 7 ancestors in all.
5 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)
- K953838: Myocardial Protection System, Quest Medical, Inc. (1996) Summary page 2.

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

## Indications for use
The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist 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

Source page: https://510kreport.com/device/K994274
Methodology: https://510kreport.com/methodology