Cleared Traditional

K955711 - BREATHE RIGHT NASAL STRIP

K955711 is an FDA 510(k) clearance for BREATHE RIGHT NASAL STRIP, manufactured by Cns, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LWF cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K955711 · Cns, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Cns, Inc. devices

FDA 510(k) Submission Details - K955711

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 90d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

LWF Device Classification - Class 1, General Controls

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.

Regulatory Peers - LWF Dilator, Nasal

All 8
Devices cleared under the same product code (LWF) and FDA review panel - the closest regulatory comparables to K955711.
BREATHE FIT
K963326 · Cambridge Assoc. · Feb 1997
AIR MAX EXTERNAL NASAL DILATOR STRIP
K962400 · American White Cross, Inc. · Sep 1996
ACUTEK'S CLEARPASAGE
K962698 · Acutek Adhesive Specialties, Inc. · Sep 1996
BREATHE RIGHT NASAL STRIP
K954914 · Cns, Inc. · Feb 1996
BURGET NASAL STENT
K942025 · Bivona Medical Technologies · Oct 1995