# FAP: Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

- Device class: 2; regulation: 21 CFR 876.1620; FDA's rule: 510(k) exempt
- FDA decisions: 85
- Recalls: 3 (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)
- 1989: 2
- 1990: 6
- 1991: 10
- 1992: 13
- 1993: 5
- 1994: 1
- 1996: 1
- 1997: 1
- 1998: 1
- 2012: 1

## Most-cited predicates
- K913736: Dobbhoff Anorect Biofeed Syst Five Div Fecal Const (1992), cited by 2
- K920575: Merkur 4000 (1992), cited by 2
- K904386: Urolab Janus (1990), cited by 1
- K920451: Endotek Ultra System (1992), cited by 1
- K904646: Bci-100 Fecal Incontinence System (1991), cited by 1
- K921047: Model 8100 Urodynamics Measuring System (1992), cited by 1
- K924383: Synectics Liberty System, PC Polygraf/Polygram Uro (1993), cited by 1
- K902843: Biosearch Anal Biofeedback Device (1990), cited by 1
- K912451: Urodynamic Rectal Balloon (1991), cited by 1
- K912701: Dantec Menuet (1991), cited by 1

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