# LJE: Catheter, Nephrostomy

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 257 days (middle half 196–260)
- Recalls: 7 (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)
- 2012: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 4
- 2020: 2
- 2022: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter (2012), cited by 3
- K833762: Percutaneous Retrograde Nephrostomy (1984), cited by 2
- K051316: X-Force Nephrostomy Balloon Dilation Catheter (2005), cited by 2
- K024050: Cook Nephrostomy Dilation Balloon Catheter Set (2003), cited by 2
- K953547: Manan Nephrostomy Drainage Catheter (1995), cited by 1
- K171601: Ultraxx Nephrostomy Balloon Catheter (2018), cited by 1
- K952968: Dilatation Catheter, Balloon (1995), cited by 1
- K842899: Curity Suprapubic Drainage System (1984), cited by 1
- K183035: Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar Needle (2019), cited by 1
- K953713: Manan General Utility Drainage Catheter (1996), cited by 1

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