Cleared Traditional

EXPANDACEL NASAL TAMPONS (K904624) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

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

Submission Details

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.

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.