# DXX: System, Catheter Control, Steerable

- Device class: 2; regulation: 21 CFR 870.1290; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 148 days (middle half 109–209)
- Recalls: 2 (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: 4
- 2013: 1
- 2014: 4
- 2015: 4
- 2016: 2
- 2018: 3
- 2020: 1
- 2022: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K021555: Stereotaxis Niobe Magnetic Navigation System (2003), cited by 4
- K120834: Corpath 200 System (2012), cited by 3
- K090365: Hansen Medical Artisan S Control Catheter (2009), cited by 2
- K160121: CorPath GRX System (2016), cited by 2
- K102168: Sensei X Robotic Catheter System (2010), cited by 2
- K141614: Magellan Robotic System (2014), cited by 2
- K091808: Sensei Robotic Catheter System, Model 02057 (2009), cited by 2
- K132369: Magellan Robotic System, Magellan Robotic Catheter 9FR (2013), cited by 2
- K073225: Sensei Catheter Control System (2008), cited by 2
- K052480: Hansen Medical Catheter Control System (CCS) and Accessories, Hansen Medical Steerable Guide Catheter (SGC) and Sheath (2007), cited by 2

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