Cleared Special

K103004 - SNORE GUARD

K103004 is an FDA 510(k) clearance for SNORE GUARD, manufactured by Ranir, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 140-day FDA review.

K103004 · Ranir, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
140d
Days
Class 2
Risk

K103004 is an FDA 510(k) clearance for the SNORE GUARD. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Ranir, LLC (Washington, US). The FDA issued a Cleared decision on February 25, 2011 after a review of 140 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ranir, LLC devices

FDA 510(k) Submission Details - K103004

510(k) Number K103004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date February 25, 2011
Days to Decision 140 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

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 K103004.
Snorer's Friend
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RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004