Cleared Traditional

K240666 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)

Also marketed or referenced as:
Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841) Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

K240666 is an FDA 510(k) clearance for Affinity Fusion Oxygenator with Integra..., manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K240666 · Medtronic Perfusion Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
124d
Days
Class 2
Risk

K240666 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2024 after a review of 124 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 Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K240666

510(k) Number K240666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2024
Decision Date July 10, 2024
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
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 235
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K240666.
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300)
K250821 · Eurosets S.R.L · Dec 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
K242503 · Eurosets S.R.L · Nov 2025
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
K231982 · Qura S.R.L · Sep 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
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, 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
K231773 · Qura S.R.L · Nov 2023