Cleared Traditional

TERUMO ROCSAFE HYBRID PERFUSION SYSTEM (K082321) - FDA 510(k) Clearance

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

K082321 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Feb 2009
Decision
184d
Days
Class 2
Risk

K082321 is an FDA 510(k) clearance for the TERUMO ROCSAFE HYBRID PERFUSION SYSTEM. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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

Submission Details

510(k) Number K082321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date February 13, 2009
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 25
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K082321.
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · Medtronic, Inc. · Jun 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
CAPIOX SP PUMP HEAD
K962981 · Terumo Medical Corp. · Feb 1997
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · Baxter Healthcare Corp · Apr 1996
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
K902404 · 3M Company · Dec 1990