Cleared Special

K093832 - LEVITRONIX CENTRIMAG PRIMARY AND BACKUP...

K093832 is the FDA 510(k) clearance for LEVITRONIX CENTRIMAG PRIMARY AND BACKUP... by Levitronix, LLC. It is a Class 2 Cardiovascular device (product code DWA) cleared through the Special 510(k) pathway after a 30-day FDA review.

K093832 · Levitronix, LLC · Cardiovascular device
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Jan 2010
Decision
30d
Days
Class 2
Risk

K093832 is an FDA 510(k) clearance for the LEVITRONIX CENTRIMAG PRIMARY AND BACKUP 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 13, 2010 after a review of 30 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.

View all Levitronix, LLC devices

Submission Details

510(k) Number K093832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date January 13, 2010
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 11
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K093832.
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K842503 · Gambro, Inc. · Aug 1984