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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 / K252330

510(k) cleared

DeepRESP

Nox Medical Ehf · Nov 17, 2025 · K252330

FDA cleared the DeepRESP from Nox Medical Ehf on Nov 17, 2025 under K252330, a traditional 510(k). The device falls under product code OLZ, Automatic Event Detection Software For 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 Jul 25, 2025. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nox Medical Ehf has one other decision in the tracker over the last 12 months: K260585 (Noxturnal Web).

Questions & Answers

What did FDA clear under K252330?

K252330 is the FDA 510(k) for DeepRESP, submitted by Nox Medical Ehf. FDA's decision date was Nov 17, 2025, under product code OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph).

Who makes the DeepRESP?

Nox Medical Ehf, based in Reykjavik, is the applicant of record for K252330.

How long did the K252330 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Nov 17, 2025, 115 days later.

← All decisions in November 2025

Sources