# K131966: Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System

- Pathway: 510(k) (Special)
- Applicant: Twin Star Medical, Inc.
- Decided: Feb 7, 2014 after 224 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: 3 generations back to K844214 (1985). 6 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090961: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II), Twin Star Medical, Inc. (2009) Summary page 2.

## Most influential descendants
- 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
- K220952: MY01 Continuous Compartmental Pressure Monitor (2022), 2 descendants of its own
- K242997: MY01 Continuous Compartmental Pressure Monitor (2025), 1 descendant of its own

## Indications for use
The Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.

Source page: https://510kreport.com/device/K131966
Methodology: https://510kreport.com/methodology