OCT · Class II · 21 CFR 876.1500

FDA Product Code OCT: Anti Fog Solution And Accessories, Endoscopy

To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.

Leading manufacturers include Minimally Invasive Devices, LLC, Advanced Medical Design Co., Ltd. and Deroyal Industries, Inc..

27
Total
27
Cleared
163d
Avg days
1991
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times: 142d avg (recent)

FDA 510(k) Cleared Anti Fog Solution And Accessories, Endoscopy Devices (Product Code OCT)

27 devices
1–24 of 27
Cleared Aug 27, 2025
KnoxFog Anti-fogging Device
K251068
Uv One Hygienics, Inc.
General & Plastic Surgery · 142d
Cleared Feb 26, 2024
GOLFF Sterile Anti-Fog Solution
K231822
Batrik Medical Manufacturing, Inc.
Gastroenterology & Urology · 250d
Cleared Jul 07, 2022
E-Brik Visualization Assistant
K221293
Jdi Surgical, Inc.
General & Plastic Surgery · 64d
Cleared Aug 27, 2020
Konix Anti-Fog Solution
K190864
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
Gastroenterology & Urology · 512d
Cleared Jan 22, 2019
AMD Anti-Fog Solution
K181887
Advanced Medical Design Co., Ltd.
Gastroenterology & Urology · 193d
Cleared May 24, 2017
VitreOx Anti-fog Solution
K163257
Sio2 Nanotech, LLC
Gastroenterology & Urology · 191d
Cleared Feb 04, 2016
Medline Anti-Fog Solution
K152948
Medline Industries, Inc.
Gastroenterology & Urology · 121d
Cleared May 11, 2012
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
K120821
Misder, LLC
Gastroenterology & Urology · 53d
Cleared Sep 09, 2011
UNIMAX ANTI-FOG SOLUTION
K111622
Unimax Medical Systems, Inc.
Gastroenterology & Urology · 91d
Cleared Dec 23, 2010
DEFOGGING AND CLEANING SOLUTION- FLO-X
K102452
Minimally Invasive Devices, LLC
Gastroenterology & Urology · 118d
Cleared Nov 06, 2008
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
K080613
Minimally Invasive Devices, LLC
Gastroenterology & Urology · 247d
Cleared Jan 09, 2007
XODUS MEDICAL ANTI-FOG SOLUTION
K063587
Xodus Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Aug 30, 2005
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979
O.R. Solutions, Inc.
Gastroenterology & Urology · 40d
Cleared Oct 09, 2002
CLEAR-IT ANTI-FOG, MODEL PS003
K022826
Preservation Solutions, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 03, 2000
ENDOSCOPIC ANTI FOG DEVICE
K993604
Mectra Labs, Inc.
Gastroenterology & Urology · 130d
Cleared Aug 11, 1998
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465
Deroyal Industries, Inc.
Gastroenterology & Urology · 27d
Cleared Dec 18, 1997
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454
Tucson Medical Corp.
Gastroenterology & Urology · 23d
Cleared Jan 04, 1995
FOG FREE
K945732
Tonn Chemical Co., Inc.
Gastroenterology & Urology · 42d
Cleared Jul 05, 1994
CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE
K942576
White Knight Healthcare
Gastroenterology & Urology · 35d
Cleared Mar 25, 1994
FOGLESS
K923843
Sorex Medical
Gastroenterology & Urology · 602d
Cleared Mar 07, 1994
EAGLE MEDICAL ANTI-FOG KIT
K933618
Eagle Medical Intl.
Gastroenterology & Urology · 231d
Cleared Feb 28, 1994
SURGICOT FOG FREE
K934291
Ssa Aquisition Corp.
Gastroenterology & Urology · 179d
Cleared Sep 17, 1993
U.C.E.Z. LENS CLEANER KIT
K925659
Anago, Inc.
Gastroenterology & Urology · 345d
Cleared Sep 17, 1993
FOG CONTROL, LENS FOG REDUCTION DEVICE
K932300
Highpoint Medical Corp.
Gastroenterology & Urology · 128d

About Product Code OCT - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code OCT since 1991, with 27 receiving FDA clearance (average review time: 163 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - OCT Product Code

FDA review times for OCT submissions have been consistent, averaging 142 days recently vs 164 days historically.

OCT devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →