Cleared Traditional

K151349 - Advanced Perfusion System 1 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151349 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
99d
Days
Class 2
Risk

K151349 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 August 27, 2015 after a review of 99 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K151349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2015
Decision Date August 27, 2015
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
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 51
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K151349.
Essenz HLM, Essenz ILBM
K232291 · Livanova Deutschland, GmbH · Aug 2023
Terumo Advanced Perfusion System 1
K221895 · Terumo Cardiovascular Systems Corporation · Apr 2023
Essenz HLM
K221373 · Livanova Deutschland, GmbH · Mar 2023
Stockert S5 System
K210130 · Livanova Deutschland, GmbH · Apr 2021
Century Perfusion System
K202125 · Century Hlm, LLC · Mar 2021
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
K190282 · Spectrum Medical , Ltd. · May 2019