# FAD: Stent, Ureteral

- Device class: 2; regulation: 21 CFR 876.4620; FDA's rule: 510(k) required
- FDA decisions: 122
- 510(k) review time 2021–2025: median 203 days (middle half 142–265)
- Recalls: 54 (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)
- 2016: 4
- 2017: 8
- 2018: 9
- 2019: 5
- 2020: 1
- 2021: 2
- 2022: 5
- 2024: 1
- 2025: 4
- 2026: 1

## Most-cited predicates
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System (2014), cited by 6
- K151051: Universa Soft Ureteral Stents and Stent Sets (2016), cited by 5
- K981591: Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent (1998), cited by 4
- K881744: Porges Ureteral Stent (1988), cited by 4
- K961446: AQ Hydrophilic Stent (1996), cited by 3
- K043193: Bard Inlayoptima Ureteral Stent with Suture (2004), cited by 3
- K161236: Universa Firm Ureteral Stents and Stent Sets (2017), cited by 3
- K022447: Bard ER Ureteral Stent with Suture (2003), cited by 2
- K013921: Porges Silicone Double Loop Ureteral Stent, Model # AJ4X / BJ1X / BJ2X (2002), cited by 2
- K033210: Bioteq Double Pigtail Ureteral Stent Set (2004), cited by 2

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