Cleared Traditional

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE (K081221) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081221 · Levitronix, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 36
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K081221.
INSPIRA ART100
K232788 · Inspira Technologies Oxy B.H.N. , Ltd. · May 2024
Anivia SG1000 Pump Console
K230698 · Apmtd, Inc. · Apr 2023
Anivia SG1000 Pump Console
K221491 · Apmtd, Inc. · Feb 2023
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
K192838 · Spectrum Medical , Ltd. · Apr 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306 · Abbott (Formerly Thoratec Corporation) · Mar 2020
CentriMag Acute Circulatory Support System
K191557 · Thoratec Corporation (Now Part of Abbott) · Jul 2019