# GWF: Stimulator, Electrical, Evoked Response

- Device class: 2; regulation: 21 CFR 882.1870; FDA's rule: 510(k) required
- FDA decisions: 141
- 510(k) review time 2021–2025: median 94 days (middle half 60–181)
- Recalls: 5 (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)
- 2016: 1
- 2017: 3
- 2019: 1
- 2020: 1
- 2021: 2
- 2022: 2
- 2023: 2
- 2024: 4
- 2025: 1
- 2026: 3

## Most-cited predicates
- K083124: NIM 3.0 (2009), cited by 6
- K051864: Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 (2005), cited by 5
- K051357: DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH (2005), cited by 5
- K020400: Digitimer D185 Multipulse Cortical Stimulator (2002), cited by 5
- K061645: Magpro, Model R30 (2006), cited by 5
- K944547: Dantec Keypoint (1995), cited by 4
- K162199: Cascade IOMAX Intraoperative Monitor (2017), cited by 4
- K061113: Orthomon (2006), cited by 4
- K924723: Cadwell Sierra (1993), cited by 4
- K120979: Carefusion Nicolet Edx (2012), cited by 4

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