Cleared Special

K041061 - D731 MICRO 20 AND D733 MICRO 40 PEDIATR...

K041061 is an FDA 510(k) clearance for D731 MICRO 20 AND D733 MICRO 40 PEDIATR..., manufactured by Dideco S.P.A.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 13-day FDA review.

K041061 · Dideco S.P.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
13d
Days
Class 2
Risk

K041061 is an FDA 510(k) clearance for the D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on May 6, 2004 after a review of 13 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 Dideco S.P.A. devices

FDA 510(k) Submission Details - K041061

510(k) Number K041061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date May 06, 2004
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
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 75
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K041061.
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
K063255 · Sorin Group Italia S.R.L. · Jan 2007
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546 · Maquet Cardiopulmonary, AG · Jun 2006
CAPIOX AF125X ARTERIAL FILTER
K052205 · Terumo Cardiovascular Systems Corp. · Sep 2005
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · Cobe Cardiovascular, Inc. · Feb 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · Dideco S.P.A. · Jan 2004
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · Medtronic Perfusion Systems · Nov 2003