Cleared Traditional

BREATHE WITH EEZ (NASAL DILATOR) (K874089) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K874089 · Breathe With Eez Corp. · Ear, Nose, Throat device
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Dec 1987
Decision
77d
Days
Class 1
Risk

K874089 is an FDA 510(k) clearance for the BREATHE WITH EEZ (NASAL DILATOR). Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Breathe With Eez Corp. (Brooklyn, US). The FDA issued a Cleared decision on December 23, 1987 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Breathe With Eez Corp. devices

Submission Details

510(k) Number K874089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1987
Decision Date December 23, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 89d · This submission: 77d
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.