# OCT: Anti Fog Solution And Accessories, Endoscopy

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 142 days (middle half 103–196)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2010: 1
- 2011: 1
- 2012: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2022: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), cited by 5
- K022826: Clear-IT Anti-Fog, Model PS003 (2002), cited by 3
- K932449: DR. FOG (1993), cited by 2
- K051979: Ors Model 6000 Endoscope Holder (2005), cited by 2
- K974454: Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 (1997), cited by 2
- K982465: Deroyal Industries, Inc. Defogger (1998), cited by 2
- K063587: Xodus Medical Anti-Fog Solution (2007), cited by 1
- K163257: VitreOx Anti-fog Solution (2017), cited by 1
- K152948: Medline Anti-Fog Solution (2016), cited by 1
- K904871: Medi-Kleer (1991), cited by 1

Source page: https://510kreport.com/product-code/OCT
Data by year (CSV): https://510kreport.com/product-code/OCT.csv