Cleared Special

K090515 - ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)

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

K090515 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K090515

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.

KFM Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K090515.
LIFEBRIDGE
K103357 · Lifebridge Medizintechnik AG · Dec 2010
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K093801 · Abiomed, Inc. · Jul 2010
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K100631 · Medtronic, Inc. · Jun 2010
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051 · Levitronix, LLC · Oct 2009
MECC SET WITH BIOLINE COATING
K083794 · Maquet Cardiopulmonary, AG · Apr 2009
IMPELLA 5.0 CATHETER FAMILY
K083111 · Abiomed, Inc. · Apr 2009
K090515 · ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
Download PDF FDA Summary Maquet Cardiopulmonar…