# K041771: Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Twin Star Medical, Inc.
- Decided: Sep 14, 2004 after 76 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Intra-Compartment Pressure Monitor System: named in the summary without a submission number

## 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 Catheter System is intended for the immediate or continuous measurement 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.

Source page: https://510kreport.com/device/K041771
Methodology: https://510kreport.com/methodology