# LXC: Monitor, Pressure, Intracompartmental

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 101 days (middle half 57–149)
- 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)
- 2004: 1
- 2006: 1
- 2009: 1
- 2014: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K844214: Compartment Syndrome Pressure Monitor Sys (1985), cited by 3
- K210525: MY01 Continuous Compartmental Pressure Monitor (2021), cited by 2
- K202635: MY01 Continuous Compartmental Pressure Monitor (2020), cited by 1
- K193321: MY01 Continuous Compartmental Pressure Monitor (2020), cited by 1
- K131966: Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System (2014), cited by 1
- K041771: Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System (2004), cited by 1
- K031555: Synthes (Usa) Compartmental Pressure Monitoring System (2003), cited by 1
- K060963: Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) (2006), cited by 1
- K242997: MY01 Continuous Compartmental Pressure Monitor (2025), cited by 1
- K090961: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) (2009), cited by 1

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