Cleared Traditional

K081221 - LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

K081221 is an FDA 510(k) clearance for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, manufactured by Levitronix, LLC. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K081221 · Levitronix, LLC · Cardiovascular device
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Jun 2008
Decision
50d
Days
Class 2
Risk

K081221 is an FDA 510(k) clearance for the LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE. 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 June 19, 2008 after a review of 50 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Levitronix, LLC devices

FDA 510(k) Submission Details - K081221

510(k) Number K081221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date June 19, 2008
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 20
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K081221.
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · Sorin Group Deutschland GmbH · Sep 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · Sorin Group Deutschland GmbH · Jan 2011
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · Sorin Group Deutschland GmbH · Jul 2009
BIO-CONSOLE 560
K080824 · Medtronic Perfusion Systems · May 2008
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369 · Cardiacassist, Inc. · Aug 2006