Cleared Traditional

K081965 - MPOWRX SNORING SOLUTION

K081965 is an FDA 510(k) clearance for MPOWRX SNORING SOLUTION, manufactured by Mpowrx Health and Wellness Products, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K081965 · Mpowrx Health and Wellness Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
109d
Days
Class 2
Risk

K081965 is an FDA 510(k) clearance for the MPOWRX SNORING SOLUTION. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Mpowrx Health and Wellness Products, Inc. (Austin, US). The FDA issued a Cleared decision on October 27, 2008 after a review of 109 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 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 Mpowrx Health and Wellness Products, Inc. devices

FDA 510(k) Submission Details - K081965

510(k) Number K081965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2008
Decision Date October 27, 2008
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LRK Device, Anti-snoring

All 86
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