Cleared Special

K251744 - Affinity Pixie™ Arterial Filter with Balance™ Biosurface

Also marketed or referenced as:
Affinity® Pediatric Arterial Blood Filter

K251744 is an FDA 510(k) clearance for Affinity Pixie Arterial Filter with Bal..., manufactured by Medtronic. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 224-day FDA review.

K251744 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
224d
Days
Class 2
Risk

K251744 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 (Mounds View, US). The FDA issued a Cleared decision on January 16, 2026 after a review of 224 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. 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 - K251744

510(k) Number K251744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2025
Decision Date January 16, 2026
Days to Decision 224 days
Submission Type Special
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
99d slower than avg
Panel avg: 125d · This submission: 224d
Pathway characteristics
Modification to existing cleared device.

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 95
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K251744.
KIDS Arterial Filters
K242953 · Sorin Group Italia S.R.L. · Dec 2024
MICRO Arterial Filters
K242092 · Sorin Group Italia S.R.L. · Nov 2024
OCS Heart Leukocyte Depleting Filter
K231362 · TransMedics, Inc. · Oct 2023
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · Medtronic Perfusion Systems · Mar 2013
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · Medtronic, Inc. · Dec 2012
TERUMO PALL AL20X ARTERIAL FILTER
K121209 · Terumo Cardiovascular Systems Corporation · May 2012
K251744 · Affinity Pixie™ Arterial Filter with Balance™ Biosurface
Download PDF FDA Summary Medtronic