# DXG: Computer, Diagnostic, Pre-Programmed, Single-Function

- Device class: 2; regulation: 21 CFR 870.1435; FDA's rule: 510(k) required
- FDA decisions: 177
- 510(k) review time 2021–2025: median 155 days (middle half 130–159)
- Recalls: 11 (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: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 2
- 2020: 1
- 2021: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K082308: Modification to Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor (2008), cited by 4
- K023960: Lidcoplus Hemodynamic Monitor System, Model HM 70 (2003), cited by 4
- K072735: Pulsion Picco-2, Model 8500 (2007), cited by 4
- K060898: Pulsion Picco Plus, Model 8100 (2006), cited by 3
- K032997: Modification to: Horizon 9000WS (2003), cited by 3
- K042144: NICOM (2004), cited by 2
- K181372: Argos (2018), cited by 2
- K172259: PulsioFlex Monitoring System (2018), cited by 2
- K940415: Horizon 9000 WS (1995), cited by 2
- K062134: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor (2006), cited by 2

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