Cleared Traditional

K920394 - MEROCEL EPISTACIS KIT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K920394 · Merocel Corp. · Ear, Nose, Throat device
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Mar 1993
Decision
413d
Days
Class 1
Risk

K920394 is an FDA 510(k) clearance for the MEROCEL EPISTACIS KIT. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Merocel Corp. (Mystic, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Merocel Corp. devices

Submission Details

510(k) Number K920394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date March 18, 1993
Days to Decision 413 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
324d slower than avg
Panel avg: 89d · This submission: 413d
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.