# K210525: MY01 Continuous Compartmental Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: MY01, Inc.
- Decided: Apr 22, 2021 after 58 days
- Product code: LXC (Monitor, Pressure, Intracompartmental)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844214 (1985). 9 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K202635: MY01 Continuous Compartmental Pressure Monitor, MY01, Inc. (2020) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Jun 28, 2021 · Class II · Z-2384-2021: There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may req

## Indications for use
The MYOl 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. The MYO 1 Mobile Application is an optional application intended for storing and displaying identical pressure values from the MYO 1 Continuous Compartmental Pressure Monitor device. The data is for informational purposes only and is not intended to be used for diagnosis of any nature or active patient monitoring.

Source page: https://510kreport.com/device/K210525
Methodology: https://510kreport.com/methodology