Cleared Traditional

K924944 - INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVI...

K924944 is the FDA 510(k) clearance for INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVI... by Westmed Intl.. It is a Class 1 Ear, Nose, Throat device (product code EMX) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K924944 · Westmed Intl. · Ear, Nose, Throat device
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Jul 1993
Decision
275d
Days
Class 1
Risk

K924944 is an FDA 510(k) clearance for the INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 275 days - an extended review 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: 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 Westmed Intl. devices

Submission Details

510(k) Number K924944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date July 02, 1993
Days to Decision 275 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
186d slower than avg
Panel avg: 89d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K924944.
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K954491 · Smith & Nephew Richards, Inc. · Nov 1995
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K921199 · Smith & Nephew Richards, Inc. · Jul 1992
NASOSTAT
K800175 · Edward Weck, Inc. · Feb 1980