# FFT: Electrode, Ph, Stomach

- Device class: 1; regulation: 21 CFR 876.1400; FDA's rule: 510(k) exempt
- FDA decisions: 49
- Recalls: 6 (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)
- 1990: 3
- 1991: 3
- 1992: 3
- 1994: 2
- 1995: 3
- 1996: 2
- 1997: 1
- 2000: 1
- 2002: 1
- 2010: 1

## Most-cited predicates
- K913387: Digitrapper Mark Iii (1991), cited by 1
- K961346: PH Analysis Module (1997), cited by 1
- K931963: Sandhill Disposable Internal Reference PH Probe (1994), cited by 1
- K002028: Bravo PH Monitoring System (2000), cited by 1

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