# GWE: Stimulator, Photic, Evoked Response

- Device class: 2; regulation: 21 CFR 882.1890; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 138 days (middle half 83–248)
- Recalls: 3 (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)
- 2005: 2
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 2
- 2015: 1
- 2018: 1
- 2020: 1
- 2021: 2
- 2022: 2

## Most-cited predicates
- K023525: Retiscan, Retiport (2004), cited by 4
- K863956: Maculoscope (TM) (1986), cited by 3
- K101691: Lifelines Photic Stimulator (2010), cited by 3
- K854362: Modified Brain Atlas Iii (1986), cited by 2
- K860801: Model 8400 W/Modifications (Spectrum 32) (1986), cited by 2
- K011794: Xltek Led Goggles, Model Led-01 (2001), cited by 1
- K971214: Kilowin (1998), cited by 1
- K113785: Adherent Visual Stimulator Goggles (2012), cited by 1
- K211643: Vision Monitor - MonpackONE (2021), cited by 1
- K043367: Glaid Ocular Electrophysiology Device (2005), cited by 1

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