Cleared Abbreviated

K113569 - APNEARX

K113569 is an FDA 510(k) clearance for APNEARX, manufactured by Apnea Science Corporation. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K113569 · Apnea Science Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
90d
Days
Class 2
Risk

K113569 is an FDA 510(k) clearance for the APNEARX. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Apnea Science Corporation (Aliso Viejo, US). The FDA issued a Cleared decision on March 1, 2012 after a review of 90 days - within the typical 510(k) review window.

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 - K113569

510(k) Number K113569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date March 01, 2012
Days to Decision 90 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
38d faster than avg
Panel avg: 128d · This submission: 90d
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 Peers - LRK Device, Anti-snoring

All 214
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K113569.
PURESLEEP
K113022 · Sleep Science Partners, Inc. · Jun 2012
SOMNODENT G2
K121340 · Somnomed, Inc. · May 2012
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K103704 · Zephyr Sleep Technologies, Inc. · Mar 2012
PILLAR PALATAL IMPLANT SYSTEM
K110623 · Medtronic Xomed, Inc. · Feb 2012
DR. GREENSBURG'S HYBRID
K111680 · Always More Marketing, Inc. · Dec 2011
SNORERX 9.0
K112205 · Consumer Health Products, Inc. · Nov 2011
K113569 · APNEARX
Download PDF FDA Summary Apnea Science Corpora…