Cleared Special

K102129 - LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

K102129 is an FDA 510(k) clearance for LEVITRONIX 2ND GENERATION CENTRIMAG PRI..., 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 29-day FDA review.

K102129 · Levitronix, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
29d
Days
Class 2
Risk

K102129 is an FDA 510(k) clearance for the LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR. 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 August 27, 2010 after a review of 29 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 - K102129

510(k) Number K102129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date August 27, 2010
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K102129.
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION)
K131179 · Thoratec Corp · Jul 2013
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
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, THORATEC CENTRIMAG BACK-UP CONSOLES
K090004 · Levitronix, LLC · Jan 2009
K102129 · LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
Download PDF FDA Summary Levitronix, LLC