Cleared Traditional

K904624 - EXPANDACEL NASAL TAMPONS

K904624 is an FDA 510(k) clearance for EXPANDACEL NASAL TAMPONS, manufactured by Ron Shippert, MD. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K904624 · Ron Shippert, MD · Ear, Nose, Throat device
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Mar 1991
Decision
161d
Days
Class 1
Risk

K904624 is an FDA 510(k) clearance for the EXPANDACEL NASAL TAMPONS. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Ron Shippert, MD (Englewood, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 161 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 Ron Shippert, MD devices

FDA 510(k) Submission Details - K904624

510(k) Number K904624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date March 21, 1991
Days to Decision 161 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
72d slower than avg
Panel avg: 89d · This submission: 161d
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 13
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K904624.
EPI-STOP EPISTAXIS CATHETER
K972077 · Boston Medical Products, Inc. · Jun 1997
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
EPISTAXIS NASAL BALLOON CATHETER
K921199 · Smith & Nephew Richards, Inc. · Jul 1992
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · Bivona Medical Technologies · Aug 1990
FOX POST NASAL BALLOON CATHETER
K841040 · Inmed Corp. · Aug 1984
EPISTAXIS CATHETER/KIT
K821584 · Bivona Medical Technologies · Jun 1982