Cleared Traditional

K921220 - BREATHE RIGHT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K921220 · Cns, Inc. · Ear, Nose, Throat device
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Oct 1993
Decision
573d
Days
Class 1
Risk

K921220 is an FDA 510(k) clearance for the BREATHE RIGHT. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Cns, Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 573 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Cns, Inc. devices

Submission Details

510(k) Number K921220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date October 07, 1993
Days to Decision 573 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
484d slower than avg
Panel avg: 89d · This submission: 573d
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.