Cleared Abbreviated

K252161 - Hushd Avera

K252161 is an FDA 510(k) clearance for Hushd Avera, manufactured by Good Sleep CO Pte , Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 138-day FDA review.

K252161 · Good Sleep CO Pte , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
138d
Days
Class 2
Risk

K252161 is an FDA 510(k) clearance for the Hushd Avera. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Good Sleep CO Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on November 25, 2025 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Good Sleep CO Pte , Ltd. devices

FDA 510(k) Submission Details - K252161

510(k) Number K252161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 127d · This submission: 138d
Pathway characteristics
Standards-based clearance path.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Aztech Regulatory & Quality, LLC
Joseph Azary

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 85
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