# FJS: Catheter, Peritoneal, Long-Term Indwelling

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 60 days (middle half 60–60)
- Recalls: 5 (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)
- 2000: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2006: 2
- 2007: 2
- 2012: 3
- 2013: 1
- 2018: 1
- 2022: 1

## Most-cited predicates
- K970159: Flex-Neck PD Catheter (1997), cited by 3
- K071167: Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560 (2007), cited by 2
- K950042: Swan Neck Presternal Peritoneal Dialysis Catheter (1995), cited by 2
- K910786: Trocar (Faller Stylet) (1991), cited by 1
- K915490: Medcomp Peritoneal Dialysis Catheters (1994), cited by 1
- K862046: Swan-Neck Peritoneal Dialysis Catheters (1986), cited by 1
- K060897: Embedding Tool, Model TE-1000 (2006), cited by 1
- K961392: Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II (1997), cited by 1
- K812607: Tenckhoff Peritoneal Catheters (1981), cited by 1
- K031351: Flex-Neck PD Catheter, Infant (2003), cited by 1

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