Cleared Traditional

K240666 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) (FDA 510(k) Clearance)

Also includes:
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)

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

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

Submission Details

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.

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 Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 253
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K240666.
Lifemotion Disposable Membrane Oxygenator
K253838 · Lifemotion Medical Technology Co., Ltd. · Mar 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
K240934 · Spectrum Medical S.R.L. · Mar 2026
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