# PNO: Catheter, Percutaneous, Cutting/Scoring

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 151 days (middle half 104–264)
- Recalls: 0 (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)
- 2015: 4
- 2016: 1
- 2017: 3
- 2019: 1
- 2020: 4
- 2021: 1
- 2022: 2
- 2024: 4
- 2025: 2
- 2026: 3

## Most-cited predicates
- K082343: Vascutrak 2, Models: V14 and V18 (2008), cited by 7
- K103459: Vascutrak Pta Dilatation Catheter (2010), cited by 6
- K072225: Angiosculpt Pta Scoring Balloon Catheter (2007), cited by 6
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 (2008), cited by 5
- K050629: Angiosculpt Scoring Balloon Catheter (2005), cited by 4
- K081220: Modification to Angiosculpt Pta Scoring Balloon Catheter (2008), cited by 3
- K122685: Angiosculpt Pta Scoring Balloon Catheter (2013), cited by 3
- K063657: Vascutrak Pta Dilation Catheter (2006), cited by 3
- K100303: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy (2010), cited by 3
- K150634: AngioSculpt PTA Scoring Baloon Catheters (2015), cited by 3

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