# GYB: Media, Electroconductive

- Device class: 2; regulation: 21 CFR 882.1275; FDA's rule: 510(k) required
- FDA decisions: 69
- 510(k) review time 2021–2025: median 124 days (middle half 96–226)
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2012: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 3
- 2021: 2
- 2022: 3
- 2023: 1
- 2025: 1

## Most-cited predicates
- K111717: Electro-Gel (2012), cited by 4
- K933804: Lectron II Conductive Gel/Cadwell Electrode Gel (1994), cited by 3
- K190050: Tech Dots - Adhesive and conductive gel (2019), cited by 3
- K192606: SAC2 - Electrode Cream (2020), cited by 2
- K161654: NuFACE Gel Primer (2016), cited by 2
- K883149: TEN20 Conductive (1988), cited by 2
- K022006: Conductive Gel (2002), cited by 2
- K983964: Batch #6060 Conductive Gel (1998), cited by 1
- K033052: Conductive Eeg Electrolyte (2003), cited by 1
- K782055: Cream, Signa (1979), cited by 1

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