Cleared Special

K051209 - LEVITRONIX CENTRIMAG BACK-UP CONSOLE

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

K051209 · Levitronix, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K051209

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

KFM Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K051209.
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
K063723 · Abiomed, Inc. · May 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
ECC.O SYSTEM
K050890 · Dideco S.R.L. · May 2005
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109 · Medtronic Perfusion Systems · Feb 2005
NOVOSCI READY SYSTEM, MODEL RS-200
K033270 · Novosci Corp. · Feb 2004
K051209 · LEVITRONIX CENTRIMAG BACK-UP CONSOLE
Download PDF FDA Summary Levitronix, LLC