FDA Product Code OCT: Anti Fog Solution And Accessories, Endoscopy
To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
Leading manufacturers include Medline Industries, Inc., Advanced Medical Design Co., Ltd. and Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler.
27
Total
27
Cleared
163d
Avg days
1991
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
142d avg (recent)
FDA 510(k) Cleared Anti Fog Solution And Accessories, Endoscopy Devices (Product Code OCT)
27 devices
Cleared
Aug 27, 2025
KnoxFog Anti-fogging Device
Uv One Hygienics, Inc.
General & Plastic Surgery
142d
Cleared
Feb 26, 2024
GOLFF Sterile Anti-Fog Solution
Batrik Medical Manufacturing, Inc.
Gastroenterology & Urology
250d
Cleared
Jul 07, 2022
E-Brik Visualization Assistant
Jdi Surgical, Inc.
General & Plastic Surgery
64d
Cleared
Aug 27, 2020
Konix Anti-Fog Solution
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
Gastroenterology & Urology
512d
Cleared
Jan 22, 2019
AMD Anti-Fog Solution
Advanced Medical Design Co., Ltd.
Gastroenterology & Urology
193d
Cleared
Feb 04, 2016
Medline Anti-Fog Solution
Medline Industries, Inc.
Gastroenterology & Urology
121d
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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
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 →