Cleared Traditional

K022826 - CLEAR-IT ANTI-FOG, MODEL PS003

K022826 is an FDA 510(k) clearance for CLEAR-IT ANTI-FOG, manufactured by Preservation Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K022826 · Preservation Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
44d
Days
Class 2
Risk

K022826 is an FDA 510(k) clearance for the CLEAR-IT ANTI-FOG, MODEL PS003. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Preservation Solutions, Inc. (Bloomington, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 44 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 Preservation Solutions, Inc. devices

FDA 510(k) Submission Details - K022826

510(k) Number K022826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date October 09, 2002
Days to Decision 44 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
87d faster than avg
Panel avg: 131d · This submission: 44d
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 18
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K022826.
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
K080613 · Minimally Invasive Devices, LLC · Nov 2008
XODUS MEDICAL ANTI-FOG SOLUTION
K063587 · Xodus Medical, Inc. · Jan 2007
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979 · O.R. Solutions, Inc. · Aug 2005
ENDOSCOPIC ANTI FOG DEVICE
K993604 · Mectra Labs, Inc. · Mar 2000
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · Deroyal Industries, Inc. · Aug 1998
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · Tucson Medical Corp. · Dec 1997