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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 / K254267

510(k) cleared

NanoPress 760A-BT (760A-BT)

Mego Afek , Ltd. · Feb 24, 2026 · K254267

FDA cleared the NanoPress 760A-BT (760A-BT) from Mego Afek , Ltd. on Feb 24, 2026 under K254267, a traditional 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 30, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Mego Afek , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254267?

K254267 is the FDA 510(k) for NanoPress 760A-BT (760A-BT), submitted by Mego Afek , Ltd.. FDA's decision date was Feb 24, 2026, under product code JOW (Sleeve, Limb, Compressible).

Who makes the NanoPress 760A-BT (760A-BT)?

Mego Afek , Ltd., based in Kibbuts Afek, is the applicant of record for K254267.

How long did the K254267 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Feb 24, 2026, 56 days later.

← All decisions in February 2026