Cleared Traditional

K231773 - Quantum Perfusion Blood Oxygenator with...

K231773 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 145-day FDA review.

K231773 · Qura S.R.L · Cardiovascular device
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Nov 2023
Decision
145d
Days
Class 2
Risk

K231773 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Qu.... 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 November 8, 2023 after a review of 145 days - within the typical 510(k) review window.

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 - K231773

510(k) Number K231773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date November 08, 2023
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
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 K231773.
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)
K240666 · Medtronic Perfusion Systems · Jul 2024
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · Medtronic, Inc. · Jun 2024
D100 KIDS
K231652 · Sorin Group Italia S.R.L. · Nov 2023
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K231414 · Chalice Medical , Ltd. · Nov 2023
Affinity Fusion™ Oxygenator System
K230640 · Medtronic, Inc. · Apr 2023
OXY-1 System
K223161 · Abiomed, Inc. · Feb 2023