# FFX: System, Gastrointestinal Motility (Electrical)

- Device class: 2; regulation: 21 CFR 876.1725; FDA's rule: 510(k) required
- FDA decisions: 70
- 510(k) review time 2021–2025: median 123 days (middle half 109–125)
- Recalls: 5 (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)
- 2013: 1
- 2016: 3
- 2017: 2
- 2018: 1
- 2019: 4
- 2020: 1
- 2023: 3
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K991288: Distender Series II Barostat (1999), cited by 4
- K092850: Endoflip (2009), cited by 4
- K031169: Motility Visualization System (2003), cited by 4
- K823701: Motility Catheters (1983), cited by 3
- K120997: Barostat Software Option (2012), cited by 3
- K012232: Insight, Model S980000 (2002), cited by 3
- K160725: EndoFLIP (2016), cited by 2
- K900058: Wilson-Cook Biliary Motility Catheter (1990), cited by 2
- K052338: Solar GI (2005), cited by 2
- K062222: Unitip High Resolution Catheter (2007), cited by 2

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