Cleared Abbreviated

K112205 - SNORERX 9.0

K112205 is an FDA 510(k) clearance for SNORERX 9.0, manufactured by Consumer Health Products, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K112205 · Consumer Health Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
107d
Days
Class 2
Risk

K112205 is an FDA 510(k) clearance for the SNORERX 9.0. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Consumer Health Products, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 16, 2011 after a review of 107 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Consumer Health Products, Inc. devices

FDA 510(k) Submission Details - K112205

510(k) Number K112205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2011
Decision Date November 16, 2011
Days to Decision 107 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

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 K112205.
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
MEDTRONIC XOMED, INC.
K122391 · Medtronic Xomed, Inc. · Jan 2013
PILLAR PALATAL IMPLANT SYSTEM
K110623 · Medtronic Xomed, Inc. · Feb 2012
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · Sybron Dental Specialties, Inc. · May 2007
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · Respironics, Inc. · Feb 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · Respironics, Inc. · Feb 2004