510(k) · Cleared
Recalled · Class II · 2021MY01 Continuous Compartmental Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MY01, Inc. · LXC Monitor, Pressure, Intracompartmental
Cleared on Apr 22, 2021 as substantially equivalent to K202635 (MY01, Inc., 2020) after a 58-day review. Its family tree reaches back 6 generations to 1985. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 22, 2021
- Review
- 58 days
- Class
- Class U
- Product code
- LXC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K844214 (1985). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 5 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 4 generations backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- 3 generations backK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- 2 generations backK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 1 generation backK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- This deviceK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251900 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK223509 Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG · 2023
Most influential descendants
Showing 4 of 4 · See all- K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022 · cites it directly2descendants
- K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025 · 2 generations on1descendant
- K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026 · 3 generations on0descendants
- K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −5 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −4 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| −3 | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| −2 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −1 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| 0 (this device) | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | — |
| +1 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
| +2 | K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025 | — |
| +3 | K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2026 | — |
| +1 | K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | Compremium AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LXC device
- #1 K242997 MY01 Continuous Compartmental Pressure Monitorscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202635 | MY01 Continuous Compartmental Pressure MonitorSummary page 5…Pre-Amendment, Unclassified K210525 Page 2 of 4 PREDICATE DEVICE K202635 MYO1 Continuous Compartmental Pressure Monitor DEVICE DESCRIPTION The MY01 Continuous Compartmental Pressure Monitor (MYO1 devic… | 2020 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2021 | Class II | Z-2384-2021 | Under Investigation by firm | 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 require a slightly higher push force from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K220952 (MY01, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LXC devicesLXC Monitor, Pressure, Intracompartmental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LXC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LXC
Too few LXC 510(k)s in any year since 2007 to give a median.
Recalls per year · LXC
No recall names LXC since 2007.
Adverse event reports per year · LXC
1in 2021
MAUDE reports naming product code LXC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210525: MY01 Continuous Compartmental Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210525
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026