Cleared Traditional

K100646 - AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE

K100646 is an FDA 510(k) clearance for AFFINITY PIXIE ARTERIAL FILTER WITH BAL..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K100646 · Medtronic, Inc. · Cardiovascular device
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Dec 2010
Decision
286d
Days
Class 2
Risk

K100646 is an FDA 510(k) clearance for the AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 286 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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

FDA 510(k) Submission Details - K100646

510(k) Number K100646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2010
Decision Date December 16, 2010
Days to Decision 286 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
161d slower than avg
Panel avg: 125d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 84
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K100646.
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TERUMO PALL AL20X ARTERIAL FILTER
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D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
K112525 · Parexel International · Sep 2011
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
K093986 · Sorin Group Italia S.R.L. · Jan 2010
QUART ARTERIAL FILTER WITH SOFTLINE COATING
K090518 · Maquet Cardiopulmonary, AG · Dec 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · Sorin Group Italia S.R.L. · Dec 2009