Cleared Traditional

K062951 - TAP III ANTI-SNORING DEVICE

K062951 is an FDA 510(k) clearance for TAP III ANTI-SNORING DEVICE, manufactured by Airway Management, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K062951 · Airway Management, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
74d
Days
Class 2
Risk

K062951 is an FDA 510(k) clearance for the TAP III ANTI-SNORING DEVICE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Airway Management, Inc. (Dallas, US). The FDA issued a Cleared decision on December 12, 2006 after a review of 74 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062951

510(k) Number K062951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 12, 2006
Days to Decision 74 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
54d faster than avg
Panel avg: 128d · This submission: 74d
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 207
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K062951.
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K070327 · Sybron Dental Specialties, Inc. · May 2007
SOMNOFIT
K060795 · Strategic Counsel Sarl · Dec 2006
LAIMAD
K062333 · Steven Lamberg, D.D.S · Dec 2006
ANTI-SNORING / SLEEP APNEA DEVICE
K061688 · Tomed Dr. Toussaint GmbH · Sep 2006
TAP-T
K061732 · Airway Management, Inc. · Jul 2006
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
K060744 · O'Brien Dental Lab, Inc. · Jun 2006