Cleared Traditional

K954914 - BREATHE RIGHT NASAL STRIP (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K954914 · Cns, Inc. · Ear, Nose, Throat device
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Feb 1996
Decision
124d
Days
Class 1
Risk

K954914 is an FDA 510(k) clearance for the BREATHE RIGHT NASAL STRIP. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Cns, Inc. (Chanhassen, US). The FDA issued a Cleared decision on February 27, 1996 after a review of 124 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 Cns, Inc. devices

Submission Details

510(k) Number K954914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1995
Decision Date February 27, 1996
Days to Decision 124 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 89d · This submission: 124d
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.