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 Mar 13, 2025 as substantially equivalent to K220952 (MY01, Inc., 2022) after a 168-day review. Its family tree reaches back 8 generations to 1985. 1 later device descends from it.
- Decided
- Mar 13, 2025
- Review
- 168 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844214 (1985). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 7 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 6 generations backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- 5 generations backK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- 4 generations backK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 3 generations backK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 2 generations backK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- 1 generation backK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- This deviceK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251900 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −7 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −6 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| −5 | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| −4 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −3 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −2 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| −1 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
| 0 (this device) | K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K251900 MY01 Continuous Compartmental Pressure Monitorscore 13.1 · 9 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 |
|---|---|---|---|
| * | K220952 | MY01 Continuous Compartmental Pressure MonitorSummary page 5…vices (OHT6) Regulation Number: Pre-Amendment, Unclassified 807.92 (a)(3): PREDICATE DEVICE MY01 Continuous Compartmental Pressure Monitor, K220952 (MY01, Inc.) 807.92 (a)(4): DEVICE DESCRIPTION The MY01 Continuous Compartmental Pressure Monitor (the MY01 device) allows for c… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251900 | MY01 Continuous Compartmental Pressure Monitor | 2026 | 0 |
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 40 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K251900 (MY01, Inc., 2026) has gone furthest, with 0 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. 2025, 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 MY01 Continuous Compartmental Pressure Monitor is used for real-time and continuous
measurement of the 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/K242997 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242997: MY01 Continuous Compartmental Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242997
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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