Cleared Traditional

K924944 - INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA

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

K924944 · Westmed Intl. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K924944

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 90d · This submission: 275d
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 46
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K924944.
EPISTAT-II NASAL CATHETER
K943718 · Merocel Corp. · Sep 1994
FLUOROFILM(R)
K933800 · American Custom Medical, Inc. · Jun 1994
THE EXPANDACELL SINUS PACK
K935724 · Denver Splint Co. · May 1994
MEROCEL EPISTACIS KIT
K920394 · Merocel Corp. · Mar 1993
NASAL-SINUS PACKING
K924542 · Ultracell Medical Technologies, Inc. · Feb 1993
ULTRACELL NASAL PACKING
K920358 · Ultracell Medical Technologies, Inc. · Nov 1992
K924944 · INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
Download PDF Westmed Intl.