Cleared Special

K090515 - ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE...

K090515 is the FDA 510(k) clearance for ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Special 510(k) pathway after a 295-day FDA review.

K090515 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Dec 2009
Decision
295d
Days
Class 2
Risk

K090515 is an FDA 510(k) clearance for the ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA). 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 December 18, 2009 after a review of 295 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K090515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date December 18, 2009
Days to Decision 295 days
Submission Type Special
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
170d slower than avg
Panel avg: 125d · This submission: 295d
Pathway characteristics
Modification to existing cleared device.

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 K090515.
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · Medtronic, Inc. · Jun 2011
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
MECC SET WITH BIOLINE COATING
K083794 · Maquet Cardiopulmonary, AG · Apr 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