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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 / March 2026 / K260585

510(k) cleared

Noxturnal Web

Nox Medical Ehf · Mar 20, 2026 · K260585

FDA cleared the Noxturnal Web from Nox Medical Ehf on Mar 20, 2026 under K260585, a special 510(k). The device falls under product code OLV, Standard Polysomnograph With Electroencephalograph, regulated at 21 CFR 882.1400 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 20, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Nox Medical Ehf has one other decision in the tracker over the last 12 months: K252330 (DeepRESP).

Questions & Answers

What did FDA clear under K260585?

K260585 is the FDA 510(k) for Noxturnal Web, submitted by Nox Medical Ehf. FDA's decision date was Mar 20, 2026, under product code OLV (Standard Polysomnograph With Electroencephalograph).

Who makes the Noxturnal Web?

Nox Medical Ehf, based in Reykjavik, is the applicant of record for K260585.

How long did the K260585 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on Mar 20, 2026, 28 days later.

← All decisions in March 2026

Sources