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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 / K251506

510(k) cleared

Nelli (Version 7.11)

Neuro Event Labs OY · Nov 21, 2025 · K251506

FDA cleared the Nelli (Version 7.11) from Neuro Event Labs OY on Nov 21, 2025 under K251506, a traditional 510(k). The device falls under product code POS, Physiological Signal Based Seizure Monitoring System, regulated at 21 CFR 882.1580 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 16, 2025. The decision came 189 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 Neuro Event Labs OY in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251506?

K251506 is the FDA 510(k) for Nelli (Version 7.11), submitted by Neuro Event Labs OY. FDA's decision date was Nov 21, 2025, under product code POS (Physiological Signal Based Seizure Monitoring System).

Who makes the Nelli (Version 7.11)?

Neuro Event Labs OY, based in Tampere, is the applicant of record for K251506.

How long did the K251506 review take?

FDA received the submission on May 16, 2025 and issued its decision on Nov 21, 2025, 189 days later.

← All decisions in November 2025