Cleared Abbreviated

K170825 - SnoreRx

K170825 is an FDA 510(k) clearance for SnoreRx, manufactured by Apnea Sciences Corporation. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 151-day FDA review.

K170825 · Apnea Sciences Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
151d
Days
Class 2
Risk

K170825 is an FDA 510(k) clearance for the SnoreRx. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Apnea Sciences Corporation (Aliso Viejo, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 151 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K170825

510(k) Number K170825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date August 18, 2017
Days to Decision 151 days
Submission Type Abbreviated
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
23d slower than avg
Panel avg: 128d · This submission: 151d
Pathway characteristics
Standards-based clearance path.

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 Consultant

James Smith, Ph.D.
James Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRK Device, Anti-snoring

All 207
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