Cleared Traditional

K173716 - MPS2 Myocardial Protection System Console

K173716 is an FDA 510(k) clearance for MPS2 Myocardial Protection System Console, manufactured by Quest Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K173716 · Quest Medical, Inc. · Cardiovascular device
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Oct 2018
Decision
300d
Days
Class 2
Risk

K173716 is an FDA 510(k) clearance for the MPS2 Myocardial Protection System Console. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on October 1, 2018 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Quest Medical, Inc. devices

FDA 510(k) Submission Details - K173716

510(k) Number K173716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2017
Decision Date October 01, 2018
Days to Decision 300 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 125d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Experien Group
Ronald S Warren

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DTR Heat-exchanger, Cardiopulmonary Bypass

All 84
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K173716.
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
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MPS 3 ND Myocardial Protection System
K201984 · Quest Medical, Inc. · Nov 2020
MPS 3 Myocardial Protection System
K200438 · Quest Medical, Inc. · Jun 2020
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
K162774 · Medtronic, Inc. · Feb 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · Medtronic, Inc. · Feb 2017
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555 · Maquet Cardiopulmonary, AG · Dec 2009