Cleared Special

K090004 - LEVITRONIX

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

K090004 · Levitronix, LLC · Cardiovascular device
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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.

View all Levitronix, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 K090004.
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K131964 · Medtronic, Inc. · Jul 2013
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K971421 · C.R. Bard, Inc. · May 1998
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
K950739 · 3M Health Care, Sarns · Nov 1995
GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · Gambro, Inc. · Aug 1984