Cleared Traditional

K181107 - Elevo® Kit Snoring Intervention Device (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181107 · Zelegent, Inc. · Ear, Nose, Throat device
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Dec 2018
Decision
224d
Days
Class 2
Risk

K181107 is an FDA 510(k) clearance for the Elevo® Kit Snoring Intervention Device. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Zelegent, Inc. (Irvine, US). The FDA issued a Cleared decision on December 6, 2018 after a review of 224 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 872.5570 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Zelegent, Inc. devices

Submission Details

510(k) Number K181107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2018
Decision Date December 06, 2018
Days to Decision 224 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 89d · This submission: 224d
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - LRK Device, Anti-snoring

All 209
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