# PNG: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

- Device class: 2; regulation: 21 CFR 876.5630; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 253 days (middle half 156–291)
- 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)
- 2008: 1
- 2010: 1
- 2011: 1
- 2012: 2
- 2016: 3
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (2005), cited by 4
- K110396: Aspira Peritoneal Drainage System (2011), cited by 4
- K152105: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (2016), cited by 2
- K113854: Pleurx Peritoneal Catheter System (2012), cited by 2
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), cited by 2
- K093796: Asept Peritoneal Drainage System (2010), cited by 2
- K201155: PleurX Peritoneal Catheter System (2020), cited by 1
- K081288: Aspira Peritoneal Drainage System (2008), cited by 1
- K221779: ASEPT Peritoneal Drainage System (2023), cited by 1
- K162457: Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (2016), cited by 1

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