Cleared Traditional

K122391 - MEDTRONIC XOMED

K122391 is an FDA 510(k) clearance for MEDTRONIC XOMED, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K122391 · Medtronic Xomed, Inc. · Dental device
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Jan 2013
Decision
156d
Days
Class 2
Risk

K122391 is an FDA 510(k) clearance for the MEDTRONIC XOMED, INC.. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 10, 2013 after a review of 156 days - an extended review cycle.

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 Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K122391

510(k) Number K122391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2012
Decision Date January 10, 2013
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K122391.
REST EAZY Appliance
K172760 · Insert Molding Solutions, Inc. · Mar 2018
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
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