# OBJ: Catheter, Ultrasound, Intravascular

- Device class: 2; regulation: 21 CFR 870.1200; FDA's rule: 510(k) required
- FDA decisions: 80
- 510(k) review time 2021–2025: median 63 days (middle half 29–123)
- Recalls: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 6
- 2018: 2
- 2019: 1
- 2020: 4
- 2021: 3
- 2022: 3
- 2023: 3
- 2024: 3
- 2025: 7
- 2026: 4

## Most-cited predicates
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F (2007), cited by 11
- K133853: Viewflex Xtra Ice Catheter (2014), cited by 8
- K041134: Combomap Pressure and Flow System (2004), cited by 8
- K051679: Ilab Ultrasound Imaging System (2005), cited by 5
- K103255: Vascular Positioning System TM (VPS TM System) Stylet (2011), cited by 5
- K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05 (2007), cited by 5
- K143701: Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014 Platinum (2015), cited by 5
- K051337: Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model 8049XX-001 (2005), cited by 4
- K170263: AcuNav Diagnostic Ultrasound Catheter 8F,10F (2017), cited by 4
- K033650: Acunav 90/10 Diagnostic Ultrasound Catheter (2004), cited by 4

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