# K060963: Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)

- Pathway: 510(k) (Traditional)
- Applicant: Twin Star Medical
- Decided: Jun 6, 2006 after 60 days
- Product code: LXC (Monitor, Pressure, Intracompartmental)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844214 (1985). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844214: Compartment Syndrome Pressure Monitor Sys, Stryker Corp. (1985) Summary page 1.
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 1.

## Most influential descendants
- K090961: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) (2009), 8 descendants of its own
- K131966: Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System (2014), 7 descendants of its own
- K193321: MY01 Continuous Compartmental Pressure Monitor (2020), 6 descendants of its own
- K202635: MY01 Continuous Compartmental Pressure Monitor (2020), 5 descendants of its own
- K210525: MY01 Continuous Compartmental Pressure Monitor (2021), 4 descendants of its own

## Indications for use
The Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) is intended for the measurement and monitoring of intracompartmental pressures and the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The CMS Monitor is intended to be used in conjunction with the Twin Star Compartment Pressure Monitoring and Fluid Collection Catheter (CMS Catheter).

Source page: https://510kreport.com/device/K060963
Methodology: https://510kreport.com/methodology