Cleared Traditional

K163531 - Advanced Perfusion System 1

K163531 is an FDA 510(k) clearance for Advanced Perfusion System 1, manufactured by Terumo Cardiovascular Systems Corporation. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K163531 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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Jun 2017
Decision
173d
Days
Class 2
Risk

K163531 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 Corporation (Ann Arbor, US). The FDA issued a Cleared decision on June 7, 2017 after a review of 173 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 Terumo Cardiovascular Systems Corporation devices

FDA 510(k) Submission Details - K163531

510(k) Number K163531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date June 07, 2017
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
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 40
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K163531.
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · Spectrum Medical , Ltd. · May 2019
Quantum Pump Console
K173834 · Spectrum Medical , Ltd. · May 2018
Advanced Perfusion System 1
K172220 · Terumo Cardiovascular Systems Corporation · Aug 2017
Advanced Perfusion System 1
K153376 · Terumo Cardiovascular Systems Corporation · Dec 2015
Advanced Perfusion System 1
K151349 · Terumo Cardiovascular Systems Corporation · Aug 2015
CARDIOHELP SYSTEM
K133598 · Maquet Cardiopulmonary, AG · May 2014