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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 / December 2025 / K250743

510(k) cleared

Remvia NightGuard

Remvia · Dec 5, 2025 · K250743

FDA cleared the Remvia NightGuard from Remvia on Dec 5, 2025 under K250743, a traditional 510(k). The device falls under product code MQC, Mouthguard, Prescription as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Mar 11, 2025. The decision came 269 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 Remvia in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250743?

K250743 is the FDA 510(k) for Remvia NightGuard, submitted by Remvia. FDA's decision date was Dec 5, 2025, under product code MQC (Mouthguard, Prescription).

Who makes the Remvia NightGuard?

Remvia, based in St. Louis, MO, is the applicant of record for K250743.

How long did the K250743 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Dec 5, 2025, 269 days later.

← All decisions in December 2025