Cleared Traditional

K131618 - LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 (FDA 510(k) Clearance)

Also includes:
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST

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

K131618 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
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Sep 2013
Decision
116d
Days
Class 2
Risk

K131618 is an FDA 510(k) clearance for the LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 K131618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date September 27, 2013
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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.