Cleared Traditional

K122475 - ZQUIET PRO-PLUS

K122475 is an FDA 510(k) clearance for ZQUIET PRO-PLUS, manufactured by Sleeping Well, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K122475 · Sleeping Well, LLC · Dental device
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Dec 2012
Decision
115d
Days
Class 2
Risk

K122475 is an FDA 510(k) clearance for the ZQUIET PRO-PLUS. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Sleeping Well, LLC (Shelburne, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 115 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 Sleeping Well, LLC devices

FDA 510(k) Submission Details - K122475

510(k) Number K122475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date December 07, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 127d · This submission: 115d
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 K122475.
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
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