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The Tracker / September 2026 / K261438

510(k) cleared

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

Eurosets S.R.L · Sep 14, 2026 · K261438

FDA cleared the HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) from Eurosets S.R.L on Sep 14, 2026 under K261438, a traditional 510(k). The device falls under product code DTZ, Oxygenator, Cardiopulmonary Bypass, regulated at 21 CFR 870.4350 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 30, 2026. The decision came 137 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Eurosets S.R.L has 2 other decisions in the tracker over the last 12 months: K250821 (Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)), K242503 (Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)).

Questions & Answers

What did FDA clear under K261438?

K261438 is the FDA 510(k) for HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305), submitted by Eurosets S.R.L. FDA's decision date was Sep 14, 2026, under product code DTZ (Oxygenator, Cardiopulmonary Bypass).

Who makes the HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)?

Eurosets S.R.L, based in Medolla, is the applicant of record for K261438.

How long did the K261438 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Sep 14, 2026, 137 days later.

← All decisions in September 2026

Sources