Product code OCT
- Device name
- Anti Fog Solution And Accessories, Endoscopy
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | 2025-08-27 |
| K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. | 2024-02-26 |
| K221293 | E-Brik Visualization Assistant | Jdi Surgical, Inc. | 2022-07-07 |
| K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020-08-27 |
| K181887 | AMD Anti-Fog Solution | Advanced Medical Design Co., Ltd. | 2019-01-22 |
| K163257 | VitreOx Anti-fog Solution | Sio2 Nanotech, LLC | 2017-05-24 |
| K152948 | Medline Anti-Fog Solution | Medline Industries, Inc. | 2016-02-04 |
| K120821 | LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM | Misder, LLC | 2012-05-11 |
| K111622 | UNIMAX ANTI-FOG SOLUTION | Unimax Medical Systems, Inc. | 2011-09-09 |
| K102452 | DEFOGGING AND CLEANING SOLUTION- FLO-X | Minimally Invasive Devices, LLC | 2010-12-23 |
| K080613 | CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008-11-06 |
| K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | Xodus Medical, Inc. | 2007-01-09 |
| K051979 | ORS MODEL 6000 ENDOSCOPE HOLDER | O.R. Solutions, Inc. | 2005-08-30 |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | Preservation Solutions, Inc. | 2002-10-09 |
| K993604 | ENDOSCOPIC ANTI FOG DEVICE | Mectra Labs, Inc. | 2000-03-03 |
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | Deroyal Industries, Inc. | 1998-08-11 |
| K974454 | CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 | Tucson Medical Corp. | 1997-12-18 |
| K945732 | FOG FREE | Tonn Chemical Co., Inc. | 1995-01-04 |
| K942576 | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE | White Knight Healthcare | 1994-07-05 |
| K923843 | FOGLESS | Sorex Medical | 1994-03-25 |
| K933618 | EAGLE MEDICAL ANTI-FOG KIT | Eagle Medical Intl. | 1994-03-07 |
| K934291 | SURGICOT FOG FREE | Ssa Aquisition Corp. | 1994-02-28 |
| K925659 | U.C.E.Z. LENS CLEANER KIT | Anago, Inc. | 1993-09-17 |
| K932300 | FOG CONTROL, LENS FOG REDUCTION DEVICE | Highpoint Medical Corp. | 1993-09-17 |
| K932449 | DR. FOG | O.R. Concepts, Inc. | 1993-08-11 |
| K904871 | MEDI-KLEER | North American Marketing Corp. | 1991-09-17 |
| K905590 | UCEZ - STERILE LENS FOG REDUCTION DEVICE | Inman Liebelt Corp. | 1991-05-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 27290019426053 | Plasma Shield | Plasmatica Ltd. | 2025-12-15 |
| 10195327105365 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-10-29 |
| 10080196693450 | Medline | MEDLINE INDUSTRIES, INC. | 2023-10-13 |
| 27290019426022 | Plasma Shield | Plasmatica Ltd. | 2023-05-17 |
| 27290019426008 | Plasma Shield | Plasmatica Ltd. | 2023-05-17 |
| 20326053102626 | Regard™ | Resource Optimization & Innovation, L.L.C. | 2019-10-30 |
| 09349967002032 | AntiFogOR | THE O R COMPANY PTY LTD | 2019-09-25 |
| 10885380166204 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-08-08 |
| 09349967001547 | Scope HelpOR Pro | THE O R COMPANY PTY LTD | 2019-03-27 |
| 00690521014626 | Anti-Fog Kit | Batrik Medical Manufacturing Inc | 2018-06-29 |
| 10885403231643 | V. Mueller | STERIS CORPORATION | 2017-11-09 |
| 00787551000115 | Anti-Fog w/ Pad; Non Sterile | XODUS MEDICAL, INC. | 2017-04-21 |
| 00787551000009 | Fog Guard Anti-Fog Solution with Sponge | XODUS MEDICAL, INC. | 2017-03-28 |
| 10810805000139 | ClearIt Anti-Fog Cloth | PRESERVATION SOLUTIONS INC | 2016-10-22 |
| 10810805000146 | ClearIt Anti-Fog Kit | PRESERVATION SOLUTIONS INC | 2016-10-11 |
| 20884521066554 | Fred Lite | Covidien LP | 2016-09-29 |
| 10885403199349 | V. Mueller | CAREFUSION 2200, INC | 2016-09-29 |
| 20884521066547 | Fred 2 | Covidien LP | 2016-09-24 |
| 10884521066496 | Fred | Covidien LP | 2016-09-24 |
| 00749756024174 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756024181 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756145732 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756301749 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756846738 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756851923 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 00749756877244 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2016-09-12 |
| 10885380009020 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-08 |
| 10885632110696 | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | 2016-08-20 |
| 10809160022757 | ActiFog™ | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 00815128020003 | FloShield/Air | MINIMALLY INVASIVE DEVICES, INC. | 2016-07-25 |