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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 / November 2025 / K251550

510(k) cleared

NX01 (NX01)

Naox Technologies Sas · Nov 25, 2025 · K251550

FDA cleared the NX01 (NX01) from Naox Technologies Sas on Nov 25, 2025 under K251550, a traditional 510(k). The device falls under product code OMC, Reduced- Montage Standard Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 21, 2025. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Naox Technologies Sas in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251550?

K251550 is the FDA 510(k) for NX01 (NX01), submitted by Naox Technologies Sas. FDA's decision date was Nov 25, 2025, under product code OMC (Reduced- Montage Standard Electroencephalograph).

Who makes the NX01 (NX01)?

Naox Technologies Sas, based in Paris, is the applicant of record for K251550.

How long did the K251550 review take?

FDA received the submission on May 21, 2025 and issued its decision on Nov 25, 2025, 188 days later.

← All decisions in November 2025