Cleared Traditional

K212341 - Quantum Perfusion Blood Oxygenator with...

K212341 is an FDA 510(k) clearance for Quantum Perfusion Blood Oxygenator with..., 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 184-day FDA review.

K212341 · Qura S.R.L · Cardiovascular device
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Jan 2022
Decision
184d
Days
Class 2
Risk

K212341 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Q.... 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 January 28, 2022 after a review of 184 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 Qura S.R.L devices

FDA 510(k) Submission Details - K212341

510(k) Number K212341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2021
Decision Date January 28, 2022
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 K212341.
Affinity Fusion™ Oxygenator System
K230640 · Medtronic, Inc. · Apr 2023
OXY-1 System
K223161 · Abiomed, Inc. · Feb 2023
CentriMag Pre-connected Pack
K222297 · Abbott · Dec 2022
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
K203424 · Qura S.R.L · Dec 2021
AMG PMP Infant
K202510 · Eurosets S.R.L · Dec 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · Medtronic · Sep 2021