Cleared Traditional

THE EXPANDACELL SINUS PACK (K935724) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K935724 · Denver Splint Co. · Ear, Nose, Throat device
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May 1994
Decision
162d
Days
Class 1
Risk

K935724 is an FDA 510(k) clearance for the THE EXPANDACELL SINUS PACK. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Denver Splint Co. (Englewood, US). The FDA issued a Cleared decision on May 12, 1994 after a review of 162 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 Denver Splint Co. devices

Submission Details

510(k) Number K935724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date May 12, 1994
Days to Decision 162 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 89d · This submission: 162d
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.