Cleared Traditional

FOG FREE (K945732) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945732 · Tonn Chemical Co., Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
42d
Days
Class 2
Risk

K945732 is an FDA 510(k) clearance for the FOG FREE. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Tonn Chemical Co., Inc. (Fort Pierce, US). The FDA issued a Cleared decision on January 4, 1995 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tonn Chemical Co., Inc. devices

Submission Details

510(k) Number K945732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date January 04, 1995
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCT Anti Fog Solution And Accessories, Endoscopy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.