Cleared Traditional

K974454 - CLEARFIELD ANTI-FOG STERILE WIPE

K974454 is an FDA 510(k) clearance for CLEARFIELD ANTI-FOG STERILE WIPE, manufactured by Tucson Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K974454 · Tucson Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
23d
Days
Class 2
Risk

K974454 is an FDA 510(k) clearance for the CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Tucson Medical Corp. (Tucson, US). The FDA issued a Cleared decision on December 18, 1997 after a review of 23 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 Tucson Medical Corp. devices

FDA 510(k) Submission Details - K974454

510(k) Number K974454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1997
Decision Date December 18, 1997
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 130d · This submission: 23d
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.

Regulatory Peers - OCT Anti Fog Solution And Accessories, Endoscopy

All 9
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K974454.
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc. · Feb 2016
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · Deroyal Industries, Inc. · Aug 1998
U.C.E.Z. LENS CLEANER KIT
K925659 · Anago, Inc. · Sep 1993
DR. FOG
K932449 · O.R. Concepts, Inc. · Aug 1993