Cleared Special

K093986 - AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS

K093986 is an FDA 510(k) clearance for AF 620 PH.I.S.I.O., manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 29-day FDA review.

K093986 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
29d
Days
Class 2
Risk

K093986 is an FDA 510(k) clearance for the AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on January 22, 2010 after a review of 29 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.

FDA 510(k) Submission Details - K093986

510(k) Number K093986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2009
Decision Date January 22, 2010
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K093986.
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K112525 · Parexel International · Sep 2011
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · Medtronic, Inc. · Dec 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
TERUMO PALL AL3X ARTERIAL FILTER
K083747 · Terumo Cardiovascular Systems Corp. · Aug 2009
K093986 · AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
Download PDF FDA Summary Sorin Group Italia S.…