Cleared Traditional

K933800 - FLUOROFILM(R)

K933800 is an FDA 510(k) clearance for FLUOROFILM, manufactured by American Custom Medical, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 324-day FDA review.

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

FDA 510(k) Submission Details - K933800

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
234d slower than avg
Panel avg: 90d · This submission: 324d
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 31
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K933800.
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
EPISTAXIS BALLOON CATHETER WITH PACKING
K945554 · Ultracell Medical Technologies, Inc. · Feb 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556 · Ultracell Medical Technologies, Inc. · Jan 1995
NASAL-SINUS PACKING
K924542 · Ultracell Medical Technologies, Inc. · Feb 1993
ULTRACELL NASAL PACKING
K920358 · Ultracell Medical Technologies, Inc. · Nov 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · Smith & Nephew Richards, Inc. · Jul 1992