# MYE: System, Electrogastrography (Egg)

- Device class: 2; regulation: 21 CFR 876.1735; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 118 days (middle half 96–157)
- Recalls: 0 (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)
- 1999: 1
- 2002: 1
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN990005: The 3PM Egg Machine (1999), cited by 3
- K014269: Polygram Net Electrogastrography Application Software, Model 9043S0151; Polygraf ID, Model 9043G0102 (2002), cited by 2
- K252504: Gastric Alimetry (2025), cited by 1
- K232925: Gastric Alimetry System (2023), cited by 1
- K240946: Gastric Alimetry (2024), cited by 1
- K223398: Gastric Alimetry System (2023), cited by 1
- K213924: Gastric Alimetry System (2022), cited by 1

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