# FEN: Device, Cystometric, Hydraulic

- Device class: 2; regulation: 21 CFR 876.1620; FDA's rule: 510(k) exempt
- FDA decisions: 36
- 510(k) review time 2021–2025: median 105 days (middle half 105–105)
- Recalls: 1 (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)
- 1991: 3
- 1993: 7
- 1994: 3
- 1995: 11
- 1996: 3
- 1997: 3
- 1998: 1
- 2000: 2
- 2008: 2
- 2021: 1

## Most-cited predicates
- K073552: Laborie Urodynamic System with Tetra Accessory (2008), cited by 2
- K082701: Uronirs, Model 2000 (2008), cited by 1
- K952573: Rusch Urodynamic Rectal Balloon Catheter (1995), cited by 1

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