Cleared Traditional

K092942 - VITAL SLEEP

K092942 is an FDA 510(k) clearance for VITAL SLEEP, manufactured by The Snore Reliever Company, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K092942 · The Snore Reliever Company, LLC · Dental device
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Jan 2010
Decision
111d
Days
Class 2
Risk

K092942 is an FDA 510(k) clearance for the VITAL SLEEP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by The Snore Reliever Company, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on January 13, 2010 after a review of 111 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 The Snore Reliever Company, LLC devices

FDA 510(k) Submission Details - K092942

510(k) Number K092942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date January 13, 2010
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
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
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K092942.
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RESPIRONICS CUSTOM II ORAL APPLIANCE
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