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) Official FDA 510(k) Summary (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.

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
12d slower than avg
Panel avg: 128d · 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 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K103004.
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SNORE GUARD ADVANCE
K102118 · Ranir, LLC · Sep 2010
K103004 · SNORE GUARD
Download PDF FDA Summary Ranir, LLC