Cleared Special

K041979 - MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260

K041979 is an FDA 510(k) clearance for MPS MYOCARDIAL PROTECTION SYSTEM - MPS ..., manufactured by Quest Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Special 510(k) pathway after a 41-day FDA review.

K041979 · Quest Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
41d
Days
Class 2
Risk

K041979 is an FDA 510(k) clearance for the MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260. 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 September 2, 2004 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041979

510(k) Number K041979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2004
Decision Date September 02, 2004
Days to Decision 41 days
Submission Type Special
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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DTR Heat-exchanger, Cardiopulmonary Bypass

All 90
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K041979.
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555 · Maquet Cardiopulmonary, AG · Dec 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838 · Gish Biomedical, Inc. · Jan 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
K072583 · Maquet Cardiopulmonary, AG · Apr 2008
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
K040355 · Gish Biomedical, Inc. · Mar 2004
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
K032068 · Cardiovention, Inc. · Aug 2003
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · Cobe Cardiovascular, Inc. · Jul 2002
K041979 · MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
Download PDF FDA Summary Quest Medical, Inc.