Cleared Special

K994208 - AFFINITY 20 MICRON ARTERIAL BLOOD FILTER

K994208 is an FDA 510(k) clearance for AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 30-day FDA review.

K994208 · Medtronic Perfusion Systems · Cardiovascular device
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Jan 2000
Decision
30d
Days
Class 2
Risk

K994208 is an FDA 510(k) clearance for the AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354. 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 January 13, 2000 after a review of 30 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K994208

510(k) Number K994208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date January 13, 2000
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K994208.
CAPIOX ARTERIAL FILTER
K002026 · Terumo Medical Corp. · Sep 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
K001138 · Medtronic Vascular · Apr 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular · Feb 2000
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · Cobe Cardiovascular, Inc. · Sep 1998
CAPIOX ARTERIAL FILTER
K943917 · Terumo Medical Corp. · Jul 1995
MEDTRONIC ARTERIAL FILTER
K926413 · Medtronic Vascular · Aug 1993