# K193321: MY01 Continuous Compartmental Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: MY01, Inc.
- Decided: Jul 30, 2020 after 241 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: 4 generations back to K844214 (1985). 7 ancestors in all.
6 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)
- K131966: Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System, Twin Star Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K251900: MY01 Continuous Compartmental Pressure Monitor (2026), 0 descendants of its own

## Indications for use
The MYO01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome. The trend arrows provide a general pressure direction and are for informational purposes only. Do not rely upon the trend arrows for the diagnosis of compartment syndrome.

Source page: https://510kreport.com/device/K193321
Methodology: https://510kreport.com/methodology