# LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

- Device class: 2; regulation: 21 CFR 870.5100; FDA's rule: 510(k) required
- FDA decisions: 108
- 510(k) review time 2021–2025: median 147 days (middle half 120–236)
- Recalls: 92 (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: 9
- 2017: 6
- 2018: 7
- 2019: 1
- 2020: 1
- 2021: 6
- 2022: 5
- 2023: 4
- 2024: 4
- 2026: 6

## Most-cited predicates
- P860019: Scimed Ptca Dilatation Catheter (1986), cited by 21
- P790017: Usci Dilatation Catheter (1980), cited by 13
- P880003: Cordis Ptca Dilatation Catheter (1988), cited by 7
- K113220: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca  Dilatation Catheter (Over-the-Wire) (2012), cited by 6
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete (1982), cited by 5
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter (2011), cited by 5
- K121667: NC Quantum Apex Ptca Dilatation Catheter (Monorail) (2012), cited by 4
- K103095: Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon (2010), cited by 4
- K111544: Glider Ptca Balloon Catheter (2012), cited by 4
- K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat (2013), cited by 4

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