Cleared Traditional

K141492 - ADVANCED MEMBRANCE GAS EXCHANGE PMP STE...

K141492 is an FDA 510(k) clearance for ADVANCED MEMBRANCE GAS EXCHANGE PMP STE..., manufactured by Eurosets S.R.L. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K141492 · Eurosets S.R.L · Cardiovascular device
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Feb 2015
Decision
246d
Days
Class 2
Risk

K141492 is an FDA 510(k) clearance for the ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE). Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Eurosets S.R.L (Medolla, Modena, IT). The FDA issued a Cleared decision on February 6, 2015 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Eurosets S.R.L devices

FDA 510(k) Submission Details - K141492

510(k) Number K141492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2014
Decision Date February 06, 2015
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 203
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K141492.
EOS PMP, EOS PMP Integrated
K150489 · Sorin Group Italia S.R.L. · Jun 2015
QUADROX-i Adult/Small Adult Oxygenators
K150267 · Maquet Cardiopulmonary, AG · May 2015
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
K143073 · Medtronic, Inc. · Mar 2015
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
K142784 · Medtronic, Inc. · Oct 2014
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · Terumo Cardiovascular Systems Corporation · Jun 2014
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · Maquet Cardiopulmonary, AG · Oct 2013