Cleared Traditional

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 (K974454) - FDA 510(k) Clearance

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

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

Submission Details

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.

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.

Regulatory Peers - OCT Anti Fog Solution And Accessories, Endoscopy

All 26
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K974454.
KnoxFog Anti-fogging Device
K251068 · Uv One Hygienics, Inc. · Aug 2025
GOLFF Sterile Anti-Fog Solution
K231822 · Batrik Medical Manufacturing, Inc. · Feb 2024
E-Brik Visualization Assistant
K221293 · Jdi Surgical, Inc. · Jul 2022
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc. · Feb 2016