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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 / February 2026 / K260254

510(k) cleared

Enbio PRO

Enbio Group AG · Feb 26, 2026 · K260254

FDA cleared the Enbio PRO from Enbio Group AG on Feb 26, 2026 under K260254, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code FLE, Sterilizer, Steam, regulated at 21 CFR 880.6880 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 27, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Enbio Group AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260254?

K260254 is the FDA 510(k) for Enbio PRO, submitted by Enbio Group AG. FDA's decision date was Feb 26, 2026, under product code FLE (Sterilizer, Steam).

Who makes the Enbio PRO?

Enbio Group AG, based in Oensingen, is the applicant of record for K260254.

How long did the K260254 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Feb 26, 2026, 30 days later.

← All decisions in February 2026