510(k) · Cleared
ClearedTwin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Twin Star Medical, Inc. · LXC Monitor, Pressure, Intracompartmental
Cleared on Feb 7, 2014 as substantially equivalent to K090961 (Twin Star Medical, Inc., 2009) after a 224-day review. Its family tree reaches back 3 generations to 1985. 7 later devices descend from it.
- Decided
- Feb 7, 2014
- Review
- 224 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K844214 (1985). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 2 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 1 generation backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- This deviceK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 2 of its ownK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK242997 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · cites it directly6descendants
- K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 2 generations on5descendants
- K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · 3 generations on4descendants
- K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022 · 4 generations on2descendants
- K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −2 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −1 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| 0 (this device) | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| +1 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +2 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +3 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| +4 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
| +5 | K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025 | — |
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 | 2 | 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 |
|---|---|---|---|
| * | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Summary page 2…is substantially equivalent to the Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-lI, K09096 1). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193321 | MY01 Continuous Compartmental Pressure Monitor | 2020 | 6 |
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 29 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K193321 (MY01, Inc., 2020) has gone furthest, with 6 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. 2014, 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 Twin Star Extremity Compartment Monitor and Fluid Collection System (ECM-III) is intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131966: Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131966
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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