Cleared Special

K241352 - Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541) (FDA 510(k) Clearance)

Also includes:
Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241352 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
30d
Days
Class 2
Risk

K241352 is an FDA 510(k) clearance for the Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541). Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 12, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K241352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date June 12, 2024
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K241352.
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 Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)
K240666 · Medtronic Perfusion Systems · Jul 2024