Cleared Traditional

K150941 - Somnowell Mandibular Advancement Appliance (MAA)

K150941 is an FDA 510(k) clearance for Somnowell Mandibular Advancement Applia..., manufactured by Somnowell , Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K150941 · Somnowell , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
44d
Days
Class 2
Risk

K150941 is an FDA 510(k) clearance for the Somnowell Mandibular Advancement Appliance (MAA). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Somnowell , Ltd. (London, GB). The FDA issued a Cleared decision on May 22, 2015 after a review of 44 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.

FDA 510(k) Submission Details - K150941

510(k) Number K150941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2015
Decision Date May 22, 2015
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K150941.
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The Panthera Anti-Snoring Device
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THERASNORE
K140663 · Distar, LLC · Dec 2014
K150941 · Somnowell Mandibular Advancement Appliance (MAA)
Download PDF FDA Summary Somnowell , Ltd.