Cleared Traditional

K013687 - NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER

K013687 is an FDA 510(k) clearance for NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER, manufactured by Steven K. Sue. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K013687 · Steven K. Sue · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
202d
Days
Class 2
Risk

K013687 is an FDA 510(k) clearance for the NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Steven K. Sue (Honolulu, US). The FDA issued a Cleared decision on May 28, 2002 after a review of 202 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.

FDA 510(k) Submission Details - K013687

510(k) Number K013687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date May 28, 2002
Days to Decision 202 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
74d slower than avg
Panel avg: 128d · This submission: 202d
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 216
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K013687.
THE BREATHE EZ ANTI-SNORING DEVICE
K022891 · D&S Redhage · Feb 2003
ANTI-SNORING DEVICE OR ASD
K011723 · Pi Medical · Dec 2002
SNORE-AID MAX
K022284 · Dental Imagineers, LLC · Dec 2002
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K020893 · Dennis R. Bailey, Dds · May 2002
SLEEPBITE
K013808 · Dental Imagineers, LLC · Jan 2002
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · Dennis R. Bailey, Dds · Nov 2001
K013687 · NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
Download PDF FDA Summary Steven K. Sue