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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 / October 2025 / K251778

510(k) cleared

Remi Custom Night Guard

Remi · Oct 17, 2025 · K251778

FDA cleared the Remi Custom Night Guard from Remi on Oct 17, 2025 under K251778, a traditional 510(k). The device falls under product code OBR, Mouthguard, Over-The-Counter as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jun 10, 2025. The decision came 129 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 Remi in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251778?

K251778 is the FDA 510(k) for Remi Custom Night Guard, submitted by Remi. FDA's decision date was Oct 17, 2025, under product code OBR (Mouthguard, Over-The-Counter).

Who makes the Remi Custom Night Guard?

Remi, based in San Francisco, CA, is the applicant of record for K251778.

How long did the K251778 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Oct 17, 2025, 129 days later.

← All decisions in October 2025