Cleared Traditional

K182312 - Zyppah Anti-Snoring Device

K182312 is the FDA 510(k) clearance for Zyppah Anti-Snoring Device by Always More Marketing. It is a Class 2 Dental device (product code LRK) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K182312 · Always More Marketing · Dental device
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Jan 2019
Decision
150d
Days
Class 2
Risk

K182312 is an FDA 510(k) clearance for the Zyppah Anti-Snoring Device. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Always More Marketing (Calabasas, US). The FDA issued a Cleared decision on January 24, 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K182312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2018
Decision Date January 24, 2019
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 127d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K182312.
ZAPnea Oral Appliance
K173064 · B. Fareid, Dds, PC · Mar 2019
Kava and Kava with Herbst
K182661 · Sketchpad Innovations, LLC · Feb 2019
TrueDorsal Devices
K180691 · True Function Laboratory, Inc. · Feb 2019
SLEEPAPP
K182202 · Comfort Acrylics, Inc. · Jan 2019
Elevo® Kit Snoring Intervention Device
K181107 · Zelegent, Inc. · Dec 2018
ApnoDent Appliance
K181123 · Apnomed, Inc. · Nov 2018