Cleared Special

K111657 - AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE

K111657 is an FDA 510(k) clearance for AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Special 510(k) pathway after a 9-day FDA review.

K111657 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
9d
Days
Class 2
Risk

K111657 is an FDA 510(k) clearance for the AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 9 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K111657

510(k) Number K111657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2011
Decision Date June 23, 2011
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 66
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K111657.
TANDEMHEART PUMP
K110493 · Cardiacassist, Inc. · Sep 2011
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
K111972 · Medtronic, Inc. · Jul 2011
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
K111658 · Medtronic, Inc. · Jun 2011
LIFEBRIDGE
K111384 · Lifebridge Medizintechnik AG · May 2011
IMPELLA CONTROLLER WITH FLOW CONTROL
K110845 · Abiomed, Inc. · Apr 2011
LIFEBRIDGE
K103357 · Lifebridge Medizintechnik AG · Dec 2010