Cleared Abbreviated

K020271 - LEVITRONIX CENTRIMAG EXTRACORPOREAL BLO...

K020271 is the FDA 510(k) clearance for LEVITRONIX CENTRIMAG EXTRACORPOREAL BLO... by Levitronix, LLC. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Abbreviated 510(k) pathway after a 421-day FDA review.

K020271 · Levitronix, LLC · Cardiovascular device
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Mar 2003
Decision
421d
Days
Class 2
Risk

K020271 is an FDA 510(k) clearance for the LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Levitronix, LLC (Waltham, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Levitronix, LLC devices

Submission Details

510(k) Number K020271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2002
Decision Date March 25, 2003
Days to Decision 421 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 125d · This submission: 421d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 43
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K020271.
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · Terumo Cardiovascular Systems Corp. · Apr 2008
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
K061072 · Maquet Cardiopulmonary, AG · May 2006
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc. · May 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc. · Mar 2003
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002