Cleared Traditional

K252531 - Myosa (S1H, S1, S2, S3, S1M, S2M) (FDA 510(k) Clearance)

Also includes:
Myosa for Snorers (S1, S1M, S2)

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

K252531 · Myofunctional Research Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
202d
Days
Class 2
Risk

K252531 is an FDA 510(k) clearance for the Myosa (S1H, S1, S2, S3, S1M, S2M). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Myofunctional Research Co. (Helnsvale, AU). The FDA issued a Cleared decision on March 2, 2026 after a review of 202 days - an extended review cycle.

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. Standard predicate reliance. 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 Myofunctional Research Co. devices

Submission Details

510(k) Number K252531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2025
Decision Date March 02, 2026
Days to Decision 202 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
75d slower than avg
Panel avg: 127d · This submission: 202d
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

Dba the Eyedeas Company
Colette Cozean

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 209
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K252531.
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