Cleared Special

K031223 - SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

K031223 is an FDA 510(k) clearance for SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR, manufactured by Dideco S.P.A.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 14-day FDA review.

K031223 · Dideco S.P.A. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
14d
Days
Class 2
Risk

K031223 is an FDA 510(k) clearance for the SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 - K031223

510(k) Number K031223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2003
Decision Date May 02, 2003
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 212
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K031223.
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
K061031 · Sorin Group Italia S.R.L. · Jun 2006
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K051997 · Terumo Cardiovascular Systems Corp. · Sep 2005
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
K033323 · Dideco S.P.A. · Jan 2004
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
K023381 · Gish Biomedical, Inc. · Mar 2003
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
K022450 · Dideco S.P.A. · Oct 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · Dideco S.P.A. · Apr 2002