Cleared Traditional

K131041 - ADVANCED PERFUSION SYSTEM 1

K131041 is an FDA 510(k) clearance for ADVANCED PERFUSION SYSTEM 1, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K131041 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Feb 2014
Decision
311d
Days
Class 2
Risk

K131041 is an FDA 510(k) clearance for the ADVANCED PERFUSION SYSTEM 1. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on February 20, 2014 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K131041

510(k) Number K131041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2013
Decision Date February 20, 2014
Days to Decision 311 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
186d slower than avg
Panel avg: 125d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K131041.
Advanced Perfusion System 1
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Advanced Perfusion System 1
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CARDIOHELP SYSTEM
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CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
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