# EGJ: Device, Iontophoresis, Other Uses

- Device class: 2; regulation: 21 CFR 890.5525; FDA's rule: 510(k) required
- FDA decisions: 73
- 510(k) review time 2021–2025: median 164 days (middle half 133–214)
- Recalls: 2 (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)
- 2011: 1
- 2014: 1
- 2015: 2
- 2017: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K983484: Dupel B.L.U.E. Small Iontophoresis Electrode (1998), cited by 8
- K932621: RH-801/GS Model Transq (R)1 (1994), cited by 6
- K932620: RH-806/GS Model Transq (R)2 (1994), cited by 6
- K982668: Phoresor II,Model PM900 (1999), cited by 4
- K912015: TBD, Empi Buffered Iontophoresis Electroded MDL. 3 (1991), cited by 4
- K915444: Dupel Iontophoresis Device (1994), cited by 3
- K882554: Meditrode Kit (1988), cited by 3
- K040495: Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405 (2004), cited by 3
- K970491: Dupel II Buffered Iontophoresis Electrodes (1997), cited by 3
- K030395: Empi Action Patch Iontophoresis System (2003), cited by 3

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