# QEY: Mechanical Thrombolysis Catheter

- Device class: 2; regulation: 21 CFR 870.5150; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 62 days (middle half 41–186)
- 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)
- 2016: 2
- 2017: 3
- 2018: 1
- 2019: 5
- 2020: 3
- 2021: 3
- 2022: 1
- 2023: 2
- 2024: 1
- 2026: 2

## Most-cited predicates
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire (1998), cited by 6
- K183290: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 (2019), cited by 5
- K013635: Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion Length) (2002), cited by 5
- K050563: Ekos Peripheral Infusion System (2005), cited by 4
- K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire (1999), cited by 4
- K041517: Infusioncath (2004), cited by 3
- K981417: Squirt Fluid Delivery System (1998), cited by 3
- K060084: Lysus Infusion System (2006), cited by 3
- K030637: Ekos Peripheral Infusion System (2003), cited by 3
- K053432: Ekos Micro-Infusion System (2005), cited by 3

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