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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 / May 2026 / K261134

510(k) cleared

Dormiva Anti-Snoring Mouth Guard

Koncept Innovators, Inc. · May 14, 2026 · K261134

FDA cleared the Dormiva Anti-Snoring Mouth Guard from Koncept Innovators, Inc. on May 14, 2026 under K261134, 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 7, 2026. The decision came 37 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261134?

K261134 is the FDA 510(k) for Dormiva Anti-Snoring Mouth Guard, submitted by Koncept Innovators, Inc.. FDA's decision date was May 14, 2026, under product code LRK (Device, Anti-Snoring).

Who makes the Dormiva Anti-Snoring Mouth Guard?

Koncept Innovators, Inc., based in Myrtle Beach, SC, is the applicant of record for K261134.

How long did the K261134 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on May 14, 2026, 37 days later.

← All decisions in May 2026