Product Code: OCT FDA class 2 21 CFR 876.1500

Anti Fog Solution And Accessories, Endoscopy

Gastroenterology, Urology

The Anti-Fog Solution and Accessories for Endoscopy (product code OCT) is a gastroenterology and urology accessory used to prevent, reduce, or eliminate condensation (fogging) on endoscopic lenses during procedures, maintaining clear visualization throughout the examination. It may include solution, sprays, or other components applied to endoscope optics. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: OCT
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251068	KnoxFog Anti-fogging Device	Aug 27, 2025	Substantially Equivalent	Uv One Hygienics, Inc.
K231822	GOLFF Sterile Anti-Fog Solution	Feb 26, 2024	Substantially Equivalent	Batrik Medical Manufacturing, Inc.
K221293	E-Brik Visualization Assistant	Jul 07, 2022	Substantially Equivalent	Jdi Surgical, Inc.
K190864	Konix Anti-Fog Solution	Aug 27, 2020	Substantially Equivalent	Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
K181887	AMD Anti-Fog Solution	Jan 22, 2019	Substantially Equivalent	Advanced Medical Design Co., Ltd.
K163257	VitreOx Anti-fog Solution	May 24, 2017	Substantially Equivalent	Sio2 Nanotech, LLC
K152948	Medline Anti-Fog Solution	Feb 04, 2016	Substantially Equivalent	Medline Industries, Inc.
K120821	LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM	May 11, 2012	Substantially Equivalent	Misder, LLC
K111622	UNIMAX ANTI-FOG SOLUTION	Sep 09, 2011	Substantially Equivalent	Unimax Medical Systems, Inc.
K102452	DEFOGGING AND CLEANING SOLUTION- FLO-X	Dec 23, 2010	Substantially Equivalent	Minimally Invasive Devices, LLC
K080613	CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045	Nov 06, 2008	Substantially Equivalent	Minimally Invasive Devices, LLC
K063587	XODUS MEDICAL ANTI-FOG SOLUTION	Jan 09, 2007	Substantially Equivalent	Xodus Medical, Inc.
K051979	ORS MODEL 6000 ENDOSCOPE HOLDER	Aug 30, 2005	Substantially Equivalent	O.R. Solutions, Inc.
K022826	CLEAR-IT ANTI-FOG, MODEL PS003	Oct 09, 2002	Substantially Equivalent	Preservation Solutions, Inc.
K993604	ENDOSCOPIC ANTI FOG DEVICE	Mar 03, 2000	Substantially Equivalent	Mectra Labs, Inc.
K982465	DEROYAL INDUSTRIES, INC. DEFOGGER	Aug 11, 1998	Substantially Equivalent	Deroyal Industries, Inc.
K974454	CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004	Dec 18, 1997	Substantially Equivalent	Tucson Medical Corp.
K945732	FOG FREE	Jan 04, 1995	Substantially Equivalent	Tonn Chemical Co., Inc.
K942576	CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE	Jul 05, 1994	Substantially Equivalent	White Knight Healthcare
K923843	FOGLESS	Mar 25, 1994	Substantially Equivalent	Sorex Medical
K933618	EAGLE MEDICAL ANTI-FOG KIT	Mar 07, 1994	Substantially Equivalent	Eagle Medical Intl.
K934291	SURGICOT FOG FREE	Feb 28, 1994	Substantially Equivalent	Ssa Aquisition Corp.
K932300	FOG CONTROL, LENS FOG REDUCTION DEVICE	Sep 17, 1993	Substantially Equivalent	Highpoint Medical Corp.
K925659	U.C.E.Z. LENS CLEANER KIT	Sep 17, 1993	Substantially Equivalent	Anago, Inc.
K932449	DR. FOG	Aug 11, 1993	Substantially Equivalent	O.R. Concepts, Inc.
K904871	MEDI-KLEER	Sep 17, 1991	Substantially Equivalent	North American Marketing Corp.
K905590	UCEZ - STERILE LENS FOG REDUCTION DEVICE	May 10, 1991	Substantially Equivalent	Inman Liebelt Corp.