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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 / K253868

510(k) cleared

QuietLab Pro

QuietLab, LLC · Dec 5, 2025 · K253868

FDA cleared the QuietLab Pro from QuietLab, LLC on Dec 5, 2025 under K253868, a traditional 510(k) reviewed through the Third Party Review Program. 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 Dec 3, 2025. The decision came 2 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for QuietLab, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253868?

K253868 is the FDA 510(k) for QuietLab Pro, submitted by QuietLab, LLC. FDA's decision date was Dec 5, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the QuietLab Pro?

QuietLab, LLC, based in New York, NY, is the applicant of record for K253868.

How long did the K253868 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Dec 5, 2025, 2 days later.

← All decisions in December 2025