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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 / K250028

510(k) cleared

Anti Snore Mouthpiece

Dongguan Yiyao Science & Technology Development Co., Ltd. · Oct 3, 2025 · K250028

FDA cleared the Anti Snore Mouthpiece from Dongguan Yiyao Science & Technology Development Co., Ltd. on Oct 3, 2025 under K250028, a traditional 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 Jan 6, 2025. The decision came 270 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 Dongguan Yiyao Science & Technology Development Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250028?

K250028 is the FDA 510(k) for Anti Snore Mouthpiece, submitted by Dongguan Yiyao Science & Technology Development Co., Ltd.. FDA's decision date was Oct 3, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Anti Snore Mouthpiece?

Dongguan Yiyao Science & Technology Development Co., Ltd., based in Dongguan, is the applicant of record for K250028.

How long did the K250028 review take?

FDA received the submission on Jan 6, 2025 and issued its decision on Oct 3, 2025, 270 days later.

← All decisions in October 2025