Cleared Traditional

K203424 - Quantum Perfusion Blood Oxygenator ECC ...

K203424 is an FDA 510(k) clearance for Quantum Perfusion Blood Oxygenator ECC ..., manufactured by Qura S.R.L. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K203424 · Qura S.R.L · Cardiovascular device
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Dec 2021
Decision
392d
Days
Class 2
Risk

K203424 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxyg.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on December 17, 2021 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Qura S.R.L devices

FDA 510(k) Submission Details - K203424

510(k) Number K203424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2020
Decision Date December 17, 2021
Days to Decision 392 days
Submission Type Traditional
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
267d slower than avg
Panel avg: 125d · This submission: 392d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K203424.
OXY-1 System
K223161 · Abiomed, Inc. · Feb 2023
CentriMag Pre-connected Pack
K222297 · Abbott · Dec 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
K212341 · Qura S.R.L · Jan 2022
AMG PMP Infant
K202510 · Eurosets S.R.L · Dec 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · Medtronic · Sep 2021
EOS PMP
K211495 · Sorin Group Italia S.R.L. · Jul 2021