Cleared Traditional

K170692 - Respire Pink Series with DentiTrac

K170692 is an FDA 510(k) clearance for Respire Pink Series with DentiTrac, manufactured by Respire Medical Holding. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K170692 · Respire Medical Holding · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
80d
Days
Class 2
Risk

K170692 is an FDA 510(k) clearance for the Respire Pink Series with DentiTrac. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Respire Medical Holding (Brooklyn, US). The FDA issued a Cleared decision on May 26, 2017 after a review of 80 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.

View all Respire Medical Holding devices

FDA 510(k) Submission Details - K170692

510(k) Number K170692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date May 26, 2017
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
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 K170692.
REST EAZY Appliance
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The Panthera Anti-Snoring X3 Device
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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