510(k) · Cleared
ClearedMY01 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 Jan 16, 2026 as substantially equivalent to K242997 (MY01, Inc., 2025) after a 210-day review. Its family tree reaches back 9 generations to 1985.
- Decided
- Jan 16, 2026
- Review
- 210 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844214 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 5 generations between
- 3 generations backK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- 2 generations backK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- 1 generation backK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
- This deviceK251900 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 8 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 7 generations backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- 6 generations backK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- 5 generations backK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 4 generations backK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 3 generations backK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- 2 generations backK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- 1 generation backK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
- This deviceK251900 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −8 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −7 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| −6 | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| −5 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −4 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −3 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| −2 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
| −1 | K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025 | — |
| 0 (this device) | K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K242997 | MY01 Continuous Compartmental Pressure MonitorSummary page 5…Orthopedic Regulation Number: Pre-Amendment, Unclassified 807.92 (a)(3): PREDICATE DEVICE MY01 Continuous Compartmental Pressure Monitor, K242997 (MY01, Inc.) 807.92 (a)(4): DEVICE DESCRIPTION The MY01 Continuous Compartmental Pressure Monitor (the MY01 device) allows for c… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All LXC devicesLXC Monitor, Pressure, Intracompartmental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251900 · printed Nov 3, 2026
Cite this page
510(k) Report. “K251900: MY01 Continuous Compartmental Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K251900
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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