Cleared Special

K102118 - SNORE GUARD ADVANCE

K102118 is an FDA 510(k) clearance for SNORE GUARD ADVANCE, 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 42-day FDA review.

K102118 · Ranir, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
42d
Days
Class 2
Risk

K102118 is an FDA 510(k) clearance for the SNORE GUARD ADVANCE. 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 September 8, 2010 after a review of 42 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. 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. Low regulatory complexity profile. 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 - K102118

510(k) Number K102118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2010
Decision Date September 08, 2010
Days to Decision 42 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
86d faster than avg
Panel avg: 128d · This submission: 42d
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 K102118.
SNORE GUARD
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K093407 · Sleeping Well, LLC · Jun 2010
PASR/QUIETNITE
K093340 · Exact Supplies , Ltd. · Jun 2010
K102118 · SNORE GUARD ADVANCE
Download PDF FDA Summary Ranir, LLC