# FKO: Catheter, Peritoneal Dialysis, Single Use

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1976: 1
- 1980: 1
- 1981: 3
- 1985: 1
- 1986: 2
- 1987: 4
- 1990: 1
- 1991: 1
- 1998: 2

## Most-cited predicates
- K874650: Peritoneal Dialysis Kit (Acute and Chronic Form) (1987), cited by 1
- K910787: Titanium Connector (2 Part) (1991), cited by 1

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