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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 / November 2025 / K252161

510(k) cleared

Hushd Avera

Good Sleep CO Pte , Ltd. · Nov 25, 2025 · K252161

FDA cleared the Hushd Avera from Good Sleep CO Pte , Ltd. on Nov 25, 2025 under K252161, a abbreviated 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 Jul 10, 2025. The decision came 138 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Good Sleep CO Pte , Ltd. has one other decision in the tracker over the last 12 months: K251784 (Hushd Pro Z-Link).

Questions & Answers

What did FDA clear under K252161?

K252161 is the FDA 510(k) for Hushd Avera, submitted by Good Sleep CO Pte , Ltd.. FDA's decision date was Nov 25, 2025, under product code LRK (Device, Anti-Snoring).

Who makes the Hushd Avera?

Good Sleep CO Pte , Ltd., based in Singapore, is the applicant of record for K252161.

How long did the K252161 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Nov 25, 2025, 138 days later.

← All decisions in November 2025

Sources