Atlas FDA

OCT

27 FDA 510(k) clearances · Product code

128 daysmedian time to decision
345 days90th percentile
27clearances measured

FDA profile

Official device name
Anti Fog Solution And Accessories, Endoscopy
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
FDA definition
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Adverse events (MAUDE)
2016: 27 · 2017: 18 · 2018: 20 · 2019: 20 · 2020: 14 · 2021: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KnoxFog Anti-fogging Device (K251068)Uv One Hygienics, Inc.2025-08-27
GOLFF Sterile Anti-Fog Solution (K231822)Batrik Medical Manufacturing, Inc.2024-02-26
E-Brik Visualization Assistant (K221293)Jdi Surgical, Inc.2022-07-07
Konix Anti-Fog Solution (K190864)Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler2020-08-27
AMD Anti-Fog Solution (K181887)Advanced Medical Design Co., Ltd.2019-01-22
VitreOx Anti-fog Solution (K163257)Sio2 Nanotech, LLC2017-05-24
Medline Anti-Fog Solution (K152948)Medline Industries, Inc.2016-02-04
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM (K120821)Misder, LLC2012-05-11
UNIMAX ANTI-FOG SOLUTION (K111622)Unimax Medical Systems, Inc.2011-09-09
DEFOGGING AND CLEANING SOLUTION- FLO-X (K102452)Minimally Invasive Devices, LLC2010-12-23
CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 (K080613)Minimally Invasive Devices, LLC2008-11-06
XODUS MEDICAL ANTI-FOG SOLUTION (K063587)Xodus Medical, Inc.2007-01-09
ORS MODEL 6000 ENDOSCOPE HOLDER (K051979)O.R. Solutions, Inc.2005-08-30
CLEAR-IT ANTI-FOG, MODEL PS003 (K022826)Preservation Solutions, Inc.2002-10-09
ENDOSCOPIC ANTI FOG DEVICE (K993604)Mectra Labs, Inc.2000-03-03
DEROYAL INDUSTRIES, INC. DEFOGGER (K982465)Deroyal Industries, Inc.1998-08-11
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 (K974454)Tucson Medical Corp.1997-12-18
FOG FREE (K945732)Tonn Chemical Co., Inc.1995-01-04
CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE (K942576)White Knight Healthcare1994-07-05
FOGLESS (K923843)Sorex Medical1994-03-25
EAGLE MEDICAL ANTI-FOG KIT (K933618)Eagle Medical Intl.1994-03-07
SURGICOT FOG FREE (K934291)Ssa Aquisition Corp.1994-02-28
FOG CONTROL, LENS FOG REDUCTION DEVICE (K932300)Highpoint Medical Corp.1993-09-17
U.C.E.Z. LENS CLEANER KIT (K925659)Anago, Inc.1993-09-17
DR. FOG (K932449)O.R. Concepts, Inc.1993-08-11
MEDI-KLEER (K904871)North American Marketing Corp.1991-09-17
UCEZ - STERILE LENS FOG REDUCTION DEVICE (K905590)Inman Liebelt Corp.1991-05-10

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Every clearance here is in the API, with alerts when new ones post.