Cleared Abbreviated

K182202 - SLEEPAPP (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K182202 · Comfort Acrylics, Inc. · Dental device
Jan 2019
Decision
150d
Days
Class 2
Risk

K182202 is an FDA 510(k) clearance for the SLEEPAPP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Comfort Acrylics, Inc. (Camas, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 150 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.

Submission Details

510(k) Number K182202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date January 11, 2019
Days to Decision 150 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 158d · This submission: 150d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K182202.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · Ram.Shaw Pte. , Ltd. · Mar 2026
Myosa (S1H, S1, S2, S3, S1M, S2M)
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Park Dental Nylon MAD
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QuietLab Pro
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Hushd Avera
K252161 · Good Sleep CO Pte , Ltd. · Nov 2025
AIO Breathe
K252525 · Aiomega, LLC · Nov 2025