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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K250821

510(k) cleared

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)

Eurosets S.R.L · Dec 12, 2025 · K250821

FDA cleared the 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) from Eurosets S.R.L on Dec 12, 2025 under K250821, 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 Mar 18, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Eurosets S.R.L has one other decision in the tracker over the last 12 months: K242503 (Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)).

Questions & Answers

What did FDA clear under K250821?

K250821 is the FDA 510(k) for 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), submitted by Eurosets S.R.L. FDA's decision date was Dec 12, 2025, under product code DTZ (Oxygenator, Cardiopulmonary Bypass).

Who makes the 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)?

Eurosets S.R.L, based in Medolla, is the applicant of record for K250821.

How long did the K250821 review take?

FDA received the submission on Mar 18, 2025 and issued its decision on Dec 12, 2025, 269 days later.

← All decisions in December 2025

Sources