Cleared Traditional

K250821 - Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) (FDA 510(k) Clearance)

Also includes:
A.L. One AF Plus OXYGENATOR (US5204) Horizon CVR (US5073)

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

K250821 · Eurosets S.R.L · Cardiovascular device
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Dec 2025
Decision
269d
Days
Class 2
Risk

K250821 is an FDA 510(k) clearance for the Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CV.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Eurosets S.R.L (Medolla, IT). The FDA issued a Cleared decision on December 12, 2025 after a review of 269 days - an extended review cycle.

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 Eurosets S.R.L devices

Submission Details

510(k) Number K250821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2025
Decision Date December 12, 2025
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
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

Accurate Consultants, Inc.
Sebastian Feye

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.

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 K250821.
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
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
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · Medtronic, Inc. · Jun 2024