Cleared Traditional

K083794 - MECC SET WITH BIOLINE COATING

K083794 is the FDA 510(k) clearance for MECC SET WITH BIOLINE COATING by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K083794 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Apr 2009
Decision
120d
Days
Class 2
Risk

K083794 is an FDA 510(k) clearance for the MECC SET WITH BIOLINE COATING. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on April 21, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K083794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date April 21, 2009
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 41
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K083794.
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · Maquet Cardiopulmonary, AG · Dec 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp. · Feb 2009
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · Maquet Cardiopulmonary, AG · Sep 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
K080774 · Terumo Cardiovascular Systems Corp. · Apr 2008