Cleared Special

K051209 - LEVITRONIX CENTRIMAG BACK-UP CONSOLE

K051209 is the FDA 510(k) clearance for LEVITRONIX CENTRIMAG BACK-UP CONSOLE by Levitronix, LLC. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Special 510(k) pathway after a 120-day FDA review.

K051209 · Levitronix, LLC · Cardiovascular device
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Sep 2005
Decision
120d
Days
Class 2
Risk

K051209 is an FDA 510(k) clearance for the LEVITRONIX CENTRIMAG BACK-UP CONSOLE. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Levitronix, LLC (Waltham, US). The FDA issued a Cleared decision on September 8, 2005 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Levitronix, LLC devices

Submission Details

510(k) Number K051209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2005
Decision Date September 08, 2005
Days to Decision 120 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K051209.
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · Maquet Cardiopulmonary, AG · Sep 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · Terumo Cardiovascular Systems Corp. · Apr 2008
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072 · Maquet Cardiopulmonary, AG · May 2006
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc. · May 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc. · Mar 2003
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002