Cleared Traditional

K123351 - AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

K123351 is an FDA 510(k) clearance for AFFINITY AF100 ARTERIAL FILTER WITH CAR..., manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K123351 · Medtronic Perfusion Systems · Cardiovascular device
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Mar 2013
Decision
139d
Days
Class 2
Risk

K123351 is an FDA 510(k) clearance for the AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2013 after a review of 139 days - within the typical 510(k) review window.

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 Perfusion Systems devices

FDA 510(k) Submission Details - K123351

510(k) Number K123351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date March 19, 2013
Days to Decision 139 days
Submission Type Traditional
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
14d slower than avg
Panel avg: 125d · This submission: 139d
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 85
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K123351.
KIDS Arterial Filters
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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 BALANCE BIOSURFACE
K122760 · Medtronic, Inc. · Dec 2012
TERUMO PALL AL20X ARTERIAL FILTER
K121209 · Terumo Cardiovascular Systems Corporation · May 2012
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
K112525 · Parexel International · Sep 2011