Cleared Traditional

K100646 - AFFINITY PIXIE ARTERIAL FILTER WITH BAL...

K100646 is the FDA 510(k) clearance for AFFINITY PIXIE ARTERIAL FILTER WITH BAL... by Medtronic, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K100646.
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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
AF 840 PH.I.S.I.O. ARTERIAL FILTER
K093601 · Sorin Group Italia S.R.L. · Dec 2009
GISH ARTERIAL FILTER WITH HA COATING
K081054 · Gish Biomedical, Inc. · Jan 2009