# K202635: MY01 Continuous Compartmental Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: MY01, Inc.
- Decided: Dec 10, 2020 after 90 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: 5 generations back to K844214 (1985). 8 ancestors in all.
5 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)
- K193321: MY01 Continuous Compartmental Pressure Monitor, MY01, Inc. (2020) Summary page 5.

## Most influential descendants
- 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
- K223509: Compremium Compartment Compressibility Monitoring System (CPM#1) (2023), 0 descendants of its own

## Indications for use
The MY01 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 displayed are meant for qualitative purposes only and are not intended to have any clinical significance.

Source page: https://510kreport.com/device/K202635
Methodology: https://510kreport.com/methodology