Cleared Traditional

K100631 - AFFIITY CP CENTRIFUGAL BLOOD PUMP

K100631 is the FDA 510(k) clearance for AFFIITY CP CENTRIFUGAL BLOOD PUMP by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code KFM) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K100631 · Medtronic, Inc. · Cardiovascular device
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Jun 2010
Decision
109d
Days
Class 2
Risk

K100631 is an FDA 510(k) clearance for the AFFIITY CP CENTRIFUGAL BLOOD PUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 22, 2010 after a review of 109 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 Medtronic, Inc. devices

Submission Details

510(k) Number K100631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date June 22, 2010
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
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 K100631.
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
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
K111657 · Medtronic, Inc. · Jun 2011
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · Maquet Cardiopulmonary, AG · Dec 2009
MECC SET WITH BIOLINE COATING
K083794 · Maquet Cardiopulmonary, AG · Apr 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp. · Feb 2009