510(k) · Cleared
ClearedTwin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)
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 Jun 12, 2009 as substantially equivalent to K041771 (Twin Star Medical, Inc., 2004) and 3 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1985. 8 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 67 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K844214 (1985). 5 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 1 generation backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- This deviceK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · 4 generations on · 4 of its ownK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- Descendant · 5 generations on · 2 of its ownK220952 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemTwin Star Medical, Inc. · 2014 · cites it directly7descendants
- K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 2 generations on6descendants
- K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 3 generations on5descendants
- K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · 4 generations on4descendants
- K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −1 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +3 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +4 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| +5 | K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K041771 | Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter SystemSummary page 1…LXC Classification Panel Orthopedic Predicate Devices Twin Star Compartment Monitoring and Fluid Collection Catheter System (Catheter, K041771), Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Mon… | 2004 |
| * | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)Summary page 1…Catheter System (Catheter, K041771), Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor, K060963), Synthes (USA) Compartmental Pressure Monitoring System (K031555), Stryker Compartment Syndrome… | 2006 |
| * | K031555 | Synthes (Usa) Compartmental Pressure Monitoring SystemSummary page 1…e Monitoring and Fluid Collection Monitor (CMS Monitor, K060963), Synthes (USA) Compartmental Pressure Monitoring System (K031555), Stryker Compartment Syndrome Pressure Monitoring System (K844214). Intended use The Twin Sta… | 2003 |
| * | K844214 | Compartment Syndrome Pressure Monitor SysSummary page 1…ynthes (USA) Compartmental Pressure Monitoring System (K031555), Stryker Compartment Syndrome Pressure Monitoring System (K844214). Intended use The Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | 1985 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter System | 2014 | 7 |
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 24 years and passes through 3 companies; a new generation was cleared every 21.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131966 (Twin Star Medical, Inc., 2014) has gone furthest, with 7 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. 2009, 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 Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II) 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/K090961 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090961: Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090961
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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