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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 / K251628

510(k) cleared

Mandibular Advancement Device L07

Dcstar, Inc. · Oct 22, 2025 · K251628

FDA cleared the Mandibular Advancement Device L07 from Dcstar, Inc. on Oct 22, 2025 under K251628, 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 May 28, 2025. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dcstar, Inc. has one other decision in the tracker over the last 12 months: K251920 (Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask).

Questions & Answers

What did FDA clear under K251628?

K251628 is the FDA 510(k) for Mandibular Advancement Device L07, submitted by Dcstar, Inc.. FDA's decision date was Oct 22, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Mandibular Advancement Device L07?

Dcstar, Inc., based in New York, NY, is the applicant of record for K251628.

How long did the K251628 review take?

FDA received the submission on May 28, 2025 and issued its decision on Oct 22, 2025, 147 days later.

← All decisions in October 2025

Sources