Cleared Abbreviated

Hushd Avera

K252161 · Good Sleep CO Pte , Ltd. · Dental

Nov 2025

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K252161 is an FDA 510(k) clearance for the Hushd Avera, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Good Sleep CO Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on November 25, 2025, 138 days after receiving the submission on July 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K252161 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2025
Decision Date	November 25, 2025
Days to Decision	138 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF