# KPM: Shunt, Peritoneal

- Device class: 2; regulation: 21 CFR 876.5955; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 122 days (middle half 122–122)
- 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)
- 1984: 1
- 1988: 2
- 1989: 2
- 1990: 1
- 1994: 1
- 1997: 1
- 1998: 1
- 2001: 4
- 2017: 1
- 2023: 1

## Most-cited predicates
- K011862: Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt (2001), cited by 1
- K913728: Denver (R) Peritoneo-Subclavian Shunt (1994), cited by 1
- K822686: Denver Peritoneo-Venous Shunt (DP-VS) (1982), cited by 1
- K894756: Denver Peritoneo-Venus Shunt (1989), cited by 1

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