# GXY: Electrode, Cutaneous

- Device class: 2; regulation: 21 CFR 882.1320; FDA's rule: 510(k) required
- FDA decisions: 441
- 510(k) review time 2021–2025: median 146 days (middle half 84–231)
- Recalls: 16 (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)
- 2017: 9
- 2018: 14
- 2019: 9
- 2020: 4
- 2021: 12
- 2022: 5
- 2023: 13
- 2024: 7
- 2025: 6
- 2026: 12

## Most-cited predicates
- K780045: Electrode Cap (1978), cited by 8
- K053214: Theraknit Garment Electrode (2005), cited by 6
- K061148: Rhythmlink Disc Electrodes (2006), cited by 6
- K002734: Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106 (2000), cited by 6
- K970426: Valuetrode (1997), cited by 6
- K171459: Ceribell Instant EEG Headband (2017), cited by 5
- K123795: Axon-Bus Prosthetic System (2014), cited by 5
- K160138: Adhesive Electrodes (2016), cited by 5
- K112319: Electro-Cap System (2012), cited by 5
- K090198: Jiajian Self-Adhesive Electrode (2009), cited by 5

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