Cleared Traditional

K120665 - INVENT SNORING DEVICE (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K120665 · Ventus Medical, Inc. · Ear, Nose, Throat device
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Jun 2012
Decision
99d
Days
Class 1
Risk

K120665 is an FDA 510(k) clearance for the INVENT SNORING DEVICE. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Ventus Medical, Inc. (Hillsborough, US). The FDA issued a Cleared decision on June 12, 2012 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3900 - 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 Ventus Medical, Inc. devices

Submission Details

510(k) Number K120665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2012
Decision Date June 12, 2012
Days to Decision 99 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
10d slower than avg
Panel avg: 89d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWF Dilator, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.