# GWQ: Full-Montage Standard Electroencephalograph

- Device class: 2; regulation: 21 CFR 882.1400; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 196 days (middle half 104–270)
- Recalls: 18 (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)
- 2014: 2
- 2015: 3
- 2016: 3
- 2017: 5
- 2018: 8
- 2020: 6
- 2022: 3
- 2023: 6
- 2024: 1
- 2026: 2

## Most-cited predicates
- K991054: Bravo Multi-Modality System (1999), cited by 9
- K983533: Actiwatch (1999), cited by 6
- K930080: E*Net Neuromonitoring System (1993), cited by 6
- K992410: Actitrac (1999), cited by 5
- K143233: Mitsar-EEG (2015), cited by 5
- K946094: Cadwell Easy Ambulatory Eeg (1995), cited by 5
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (2013), cited by 5
- K040360: EMU128S, Model EX-NW-128S (2004), cited by 4
- K914571: Neurotrac II (1992), cited by 4
- K964280: DG Nervus (1997), cited by 4

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