Cleared Abbreviated

K170053 - Meridian PM

K170053 is an FDA 510(k) clearance for Meridian PM, manufactured by The Center For Craniofacial & Dental Sleep Medicine. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 327-day FDA review.

K170053 · The Center For Craniofacial & Dental Sleep Medicine · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
327d
Days
Class 2
Risk

K170053 is an FDA 510(k) clearance for the Meridian PM. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by The Center For Craniofacial & Dental Sleep Medicine (Sugarland, US). The FDA issued a Cleared decision on November 28, 2017 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

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 - K170053

510(k) Number K170053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2017
Decision Date November 28, 2017
Days to Decision 327 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
199d slower than avg
Panel avg: 128d · This submission: 327d
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

Fishermed Consulting, LLC
Cheryl Fisher

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
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K170053.
REST EAZY Appliance
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The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018
Snorer's Friend
K171529 · Scope Healthcare Technologies Pty, Ltd. · Jan 2018
True Function Adjustable Herbst Appliances
K170578 · True Function Laboratory, Inc. · Nov 2017
SnoreRx
K170825 · Apnea Sciences Corporation · Aug 2017
O2Vent W
K171316 · Oventus Manufacturing Pty, Ltd. · Jul 2017