Cleared Special

K051232 - D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTE...

K051232 is the FDA 510(k) clearance for D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTE... by Dideco S.R.L.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Special 510(k) pathway after a 7-day FDA review.

K051232 · Dideco S.R.L. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2005
Decision
7d
Days
Class 2
Risk

K051232 is an FDA 510(k) clearance for the D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O P.... Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Dideco S.R.L. (Waltham, US). The FDA issued a Cleared decision on May 20, 2005 after a review of 7 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.R.L. devices

Submission Details

510(k) Number K051232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2005
Decision Date May 20, 2005
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 59
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K051232.
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
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
K031946 · Edwards Lifesciences, LLC · Nov 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · Terumo Cardiovascular Systems Corp. · Aug 2003