Cleared Traditional

MPowRx Snoring Solution (also known as Good Morning Snore Solution) (K193239) - FDA 510(k) Clearance

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

K193239 · Mpowrx Health and Wellness Products 2012, Inc. · Dental device
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Jan 2020
Decision
39d
Days
Class 2
Risk

K193239 is an FDA 510(k) clearance for the MPowRx Snoring Solution (also known as Good Morning Snore Solution). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Mpowrx Health and Wellness Products 2012, Inc. (Calgary, CA). The FDA issued a Cleared decision on January 3, 2020 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mpowrx Health and Wellness Products 2012, Inc. devices

Submission Details

510(k) Number K193239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date January 03, 2020
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 127d · This submission: 39d
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

Arazy Group Consultants, Inc.
Ray Kelly

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 210
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