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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 / June 2026 / K261366

510(k) cleared

Virtus

Somnomed, Inc. · Jun 12, 2026 · K261366

FDA cleared the Virtus from Somnomed, Inc. on Jun 12, 2026 under K261366, a special 510(k). The device falls under product code LRK, Device, Anti-Snoring, regulated at 21 CFR 872.5570 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 27, 2026. The decision came 46 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Somnomed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261366?

K261366 is the FDA 510(k) for Virtus, submitted by Somnomed, Inc.. FDA's decision date was Jun 12, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the Virtus?

Somnomed, Inc., based in Plano, TX, is the applicant of record for K261366.

How long did the K261366 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Jun 12, 2026, 46 days later.

← All decisions in June 2026