Cleared Traditional

K102726 - CARDIOHELP SYSTEM

K102726 is the FDA 510(k) clearance for CARDIOHELP SYSTEM by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K102726 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Apr 2011
Decision
195d
Days
Class 2
Risk

K102726 is an FDA 510(k) clearance for the CARDIOHELP SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on April 4, 2011 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K102726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date April 04, 2011
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 22
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K102726.
Quantum Pump Console
K173834 · Spectrum Medical , Ltd. · May 2018
CARDIOHELP SYSTEM
K133598 · Maquet Cardiopulmonary, AG · May 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · 3M Health Care, Sarns · Jul 1992
SARNS 9000 HEART-LUNG CONSOLE
K871131 · 3M Health Care, Sarns · May 1987