Cleared Special

K153376 - Advanced Perfusion System 1

K153376 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 Special 510(k) pathway after a 23-day FDA review.

K153376 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
23d
Days
Class 2
Risk

K153376 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 December 16, 2015 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 - K153376

510(k) Number K153376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date December 16, 2015
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 51
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K153376.
Quantum Pump Console
K173834 · Spectrum Medical , Ltd. · May 2018
Advanced Perfusion System 1
K172220 · Terumo Cardiovascular Systems Corporation · Aug 2017
Advanced Perfusion System 1
K163531 · Terumo Cardiovascular Systems Corporation · Jun 2017
Advanced Perfusion System 1
K151349 · Terumo Cardiovascular Systems Corporation · Aug 2015
CARDIOHELP SYSTEM
K133598 · Maquet Cardiopulmonary, AG · May 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
K153376 · Advanced Perfusion System 1
Download PDF FDA Summary Terumo Cardiovascular…