Cleared Traditional

K041446 - NASALCEASE

K041446 is an FDA 510(k) clearance for NASALCEASE, manufactured by Les Laboratorires Brothier, S.A.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K041446 · Les Laboratorires Brothier, S.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
30d
Days
Class 1
Risk

K041446 is an FDA 510(k) clearance for the NASALCEASE. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Les Laboratorires Brothier, S.A. (Nanterre Paris, FR). The FDA issued a Cleared decision on July 1, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - 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 Les Laboratorires Brothier, S.A. devices

FDA 510(k) Submission Details - K041446

510(k) Number K041446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date July 01, 2004
Days to Decision 30 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 90d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
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 - EMX Balloon, Epistaxis

All 30
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K041446.
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