Cleared Traditional

K955711 - BREATHE RIGHT NASAL STRIP (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K955711 · Cns, Inc. · Ear, Nose, Throat device
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May 1996
Decision
164d
Days
Class 1
Risk

K955711 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. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 164 days - an extended review cycle.

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.

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Submission Details

510(k) Number K955711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date May 30, 1996
Days to Decision 164 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
75d slower than avg
Panel avg: 89d · This submission: 164d
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.