Cleared Traditional

Hushd Pro Avera (K232025) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232025 · Good Sleep CO Pte , Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
307d
Days
Class 2
Risk

K232025 is an FDA 510(k) clearance for the Hushd Pro 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 May 9, 2024 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Good Sleep CO Pte , Ltd. devices

Submission Details

510(k) Number K232025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date May 09, 2024
Days to Decision 307 days
Submission Type Traditional
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
180d slower than avg
Panel avg: 127d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Evo820, LLC
Na Zhang

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.

Regulatory Peers - LRK Device, Anti-snoring

All 79
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K232025.
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EMA 3D
K232735 · Ema Sleep Incorporated · May 2024
Difiney Anti Snoring Device
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airVata™
K240427 · Gelb Practice Solutions, Inc. · Feb 2024