Cleared Traditional

FLUOROFILM(R) (K933800) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K933800 · American Custom Medical, Inc. · Ear, Nose, Throat device
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Jun 1994
Decision
324d
Days
Class 1
Risk

K933800 is an FDA 510(k) clearance for the FLUOROFILM(R). Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by American Custom Medical, Inc. (Lubbock, US). The FDA issued a Cleared decision on June 24, 1994 after a review of 324 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 American Custom Medical, Inc. devices

Submission Details

510(k) Number K933800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date June 24, 1994
Days to Decision 324 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 89d · This submission: 324d
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.