# K251900: MY01 Continuous Compartmental Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: MY01, Inc.
- Decided: Jan 16, 2026 after 210 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: 9 generations back to K844214 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242997: MY01 Continuous Compartmental Pressure Monitor, MY01, Inc. (2025) Summary page 5.

## Indications for use
The MYO01 Continuous Compartmental Pressure Monitor is used for real-time and continuous measurement of muscle compartment pressure. The measured muscle compartment pressure can be used as an aid in diagnosis of Compartment Syndrome (Acute and Chronic). The MY01 Mobile Application is an application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device and calculating critical muscle perfusion pressure utilizing diastolic pressure manual entry by the physician. Diagnosis should always be made in conjunction with clinical assessments.

Source page: https://510kreport.com/device/K251900
Methodology: https://510kreport.com/methodology