# GWN: Nystagmograph

- Device class: 2; regulation: 21 CFR 882.1460; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 235 days (middle half 181–268)
- 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)
- 2013: 3
- 2015: 3
- 2016: 2
- 2017: 4
- 2018: 3
- 2019: 1
- 2020: 2
- 2023: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K964325: Visualeyes: Video Eye Monitor (1997), cited by 6
- K991497: Ics Medical Chartr Eng/VNG Diagnostic System (1999), cited by 5
- K143607: I-Portal NOTC, VNG and VOG (2015), cited by 4
- K042529: Balanceback VNG System (2004), cited by 3
- K972243: 2D Vog - Video-Oculography (1997), cited by 3
- K151504: ICS Impulse (2015), cited by 3
- K072254: VN415M, VN415B, VO425M, V0425B, 2D-Vog Goggles, 2D-Vog System (2008), cited by 3
- K083603: I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (VNG), I-Portal Neuro Otol (2009), cited by 3
- K925111: House Infrared/Video Electronystagmograph System (1994), cited by 2
- K964646: Video Eye Trakker (1997), cited by 2

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