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 Jul 30, 2020 as substantially equivalent to K131966 (Twin Star Medical, Inc., 2014) after a 241-day review. Its family tree reaches back 4 generations to 1985. 6 later devices descend from it.
- Decided
- Jul 30, 2020
- Review
- 241 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844214 (1985). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 3 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 2 generations backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- 1 generation backK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- This deviceK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 2 of its ownK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
- Descendant · 5 generations on · 0 of its ownK251900 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · cites it directly5descendants
- K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · 2 generations on4descendants
- K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022 · 3 generations on2descendants
- K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025 · 4 generations on1descendant
- K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −3 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −2 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| −1 | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| 0 (this device) | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +1 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +2 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| +3 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
| +4 | K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025 | — |
| +5 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemSummary page 4…Classification Name: Unclassified Classification Code: LXC Classification Panel: Orthopedic Regulation Number: Pre-Amendment, Unclassified C. PREDICATE DEVICE K131966 Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) D. DEVICE DESCRI… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202635 | MY01 Continuous Compartmental Pressure Monitor | 2020 | 5 |
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 35 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K202635 (MY01, Inc., 2020) has gone furthest, with 5 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. 2020, 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 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 provide a general pressure direction and are for informational purposes only. Do not rely upon the trend
arrows for the diagnosis of compartment syndrome.
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/K193321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193321: 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/K193321
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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