Cleared Special

K090004 - LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

K090004 is an FDA 510(k) clearance for LEVITRONIX, manufactured by Levitronix, LLC. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Special 510(k) pathway after a 13-day FDA review.

K090004 · Levitronix, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
13d
Days
Class 2
Risk

K090004 is an FDA 510(k) clearance for the LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Levitronix, LLC (Waltham, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - 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. Low regulatory complexity profile. 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 - K090004

510(k) Number K090004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date January 15, 2009
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 36
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K090004.
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
K102129 · Levitronix, LLC · Aug 2010
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
K093832 · Levitronix, LLC · Jan 2010
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · Sorin Group Deutschland GmbH · Jul 2009
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K083340 · Levitronix, LLC · Nov 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K081221 · Levitronix, LLC · Jun 2008
BIO-CONSOLE 560
K080824 · Medtronic Perfusion Systems · May 2008
K090004 · LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
Download PDF FDA Summary Levitronix, LLC