Cleared Traditional

K982465 - DEROYAL INDUSTRIES, INC. DEFOGGER

K982465 is an FDA 510(k) clearance for DEROYAL INDUSTRIES, manufactured by Deroyal Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCT cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K982465 · Deroyal Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
27d
Days
Class 2
Risk

K982465 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. DEFOGGER. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on August 11, 1998 after a review of 27 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.

FDA 510(k) Submission Details - K982465

510(k) Number K982465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date August 11, 1998
Days to Decision 27 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 131d · This submission: 27d
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 26
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K982465.
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979 · O.R. Solutions, Inc. · Aug 2005
CLEAR-IT ANTI-FOG, MODEL PS003
K022826 · Preservation Solutions, Inc. · Oct 2002
ENDOSCOPIC ANTI FOG DEVICE
K993604 · Mectra Labs, Inc. · Mar 2000
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · Tucson Medical Corp. · Dec 1997
FOG FREE
K945732 · Tonn Chemical Co., Inc. · Jan 1995
CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE
K942576 · White Knight Healthcare · Jul 1994
K982465 · DEROYAL INDUSTRIES, INC. DEFOGGER
Download PDF FDA Summary Deroyal Industries, I…