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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · 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 207
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K170692.
SnoreRx
K170825 · Apnea Sciences Corporation · Aug 2017
O2Vent W
K171316 · Oventus Manufacturing Pty, Ltd. · Jul 2017
ASD Oral Appliances
K163580 · American Sleep Dentistry · Jun 2017
Fuselier Intraoral Nighttime Device (FIND)
K161980 · Fuselier Enterprises, LLC · Feb 2017
BluePro
K162192 · Bluesom · Dec 2016
HYPNOSPAD
K152660 · Somnics, Inc. · Nov 2016