Cleared Traditional

K112587 - ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE...

K112587 is an FDA 510(k) clearance for ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE..., manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DWB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K112587 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Dec 2011
Decision
104d
Days
Class 2
Risk

K112587 is an FDA 510(k) clearance for the ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CL.... Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on December 19, 2011 after a review of 104 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 Corp. devices

FDA 510(k) Submission Details - K112587

510(k) Number K112587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2011
Decision Date December 19, 2011
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 14
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K112587.
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
K162843 · Terumo Cardiovascular Systems Corporation · Nov 2016
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618 · Terumo Cardiovascular Systems Corporation · Sep 2013
COBE CENTURY PERFUSION PUMP
K960974 · Cobe Cardiovascular, Inc. · Jul 1997
SARNS 800 ROLLER PUMP
K953901 · 3M Health Care, Sarns · Apr 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904 · 3M Health Care, Ltd. · Apr 1996
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · Shiley, Inc. · Apr 1989