Cleared Traditional

K261438 - HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)

K261438 is an FDA 510(k) clearance for HORIZON 8AF (Integrated OXY MODULE 8AF ..., manufactured by Eurosets S.R.L. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K261438 · Eurosets S.R.L · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
137d
Days
Class 2
Risk

K261438 is an FDA 510(k) clearance for the HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305). 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 September 14, 2026 after a review of 137 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 Eurosets S.R.L devices

FDA 510(k) Submission Details - K261438

510(k) Number K261438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2026
Decision Date September 14, 2026
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 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 241
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K261438.
Lifemotion Disposable Membrane Oxygenator
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K240666 · Medtronic Perfusion Systems · Jul 2024