# DXO: Transducer, Pressure, Catheter Tip

- Device class: 2; regulation: 21 CFR 870.2870; FDA's rule: 510(k) required
- FDA decisions: 64
- 510(k) review time 2021–2025: median 219 days (middle half 185–244)
- Recalls: 1 (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: 2
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 4
- 2020: 2
- 2022: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), cited by 4
- K142749: TruWave Disposable Pressure Transducer (2015), cited by 3
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), cited by 3
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter (2014), cited by 3
- K062769: Pressurewire Certus, Models 12006 and 12306 (2006), cited by 2
- K925638: Phoenix Disposable Pressure Transducer #73-600 (1993), cited by 2
- K192340: OptoMonitor (2019), cited by 2
- K053016: Wireless Physiologic Monitoring System (2005), cited by 2
- K141495: Truwave Disposable Pressure Transducer (2014), cited by 2
- K070487: Smartwire Pressure Guide Wire, Model 66XX (2007), cited by 2

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