Cleared Traditional

K231982 - Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231982 · Qura S.R.L · Cardiovascular device

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Sep 2024

Decision

435d

Days

Class 2

Risk

K231982 is an FDA 510(k) clearance for the Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenato.... 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 September 12, 2024 after a review of 435 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Qura S.R.L devices

Submission Details

510(k) Number	K231982 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 05, 2023
Decision Date	September 12, 2024
Days to Decision	435 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

310d slower than avg

Panel avg: 125d · This submission: 435d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Spectrum Medical S.R.L.

Raffaella Tommasini

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.