Hushd Avera

FDA 510(k) K252161 · Good Sleep CO Pte , Ltd.

Substantially Equivalent

510(k) numberK252161

Submission

Device name
Hushd Avera
Applicant
Good Sleep CO Pte , Ltd.
Singapore, SG
Received
July 10, 2025
Decision date
November 25, 2025
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LRK – Device, Anti-Snoring
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Specialty
Dental

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More from QuietLab, LLC

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Questions and answers

When was Hushd Avera cleared by the FDA?

Hushd Avera (K252161) received a 510(k) decision of Substantially Equivalent on November 25, 2025, 138 days after the submission was received.

What is the product code of K252161?

The FDA product code is LRK – Device, Anti-Snoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.