Cleared Traditional

K905590 - UCEZ - STERILE LENS FOG REDUCTION DEVICE

K905590 is an FDA 510(k) clearance for UCEZ - STERILE LENS FOG REDUCTION DEVICE, manufactured by Inman Liebelt Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K905590 · Inman Liebelt Corp. · Gastroenterology & Urology device
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May 1991
Decision
148d
Days
Class 2
Risk

K905590 is an FDA 510(k) clearance for the UCEZ - STERILE LENS FOG REDUCTION DEVICE. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Inman Liebelt Corp. (Arlington, US). The FDA issued a Cleared decision on May 10, 1991 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inman Liebelt Corp. devices

FDA 510(k) Submission Details - K905590

510(k) Number K905590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date May 10, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 130d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCT Device Classification - Class 2, Special Controls

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.