510(k) · Cleared
Recalled · 2005Compartment Syndrome Pressure Monitor Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · LXC Monitor, Pressure, Intracompartmental
Cleared on Apr 4, 1985 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it. It has been recalled once.
- Decided
- Apr 4, 1985
- Review
- 155 days
- Class
- Class U
- Product code
- LXC
- Recalls
- 1
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985
- Descendant · cites it directly · 9 of its ownK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- Descendant · cites it directly · 8 of its ownK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K060963Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)Twin Star Medical · 2006 · cites it directly9descendants
- K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Twin Star Medical, Inc. · 2009 · cites it directly8descendants
- K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemTwin Star Medical, Inc. · 2014 · 2 generations on7descendants
- K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020 · 3 generations on6descendants
- K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | — |
| +1 | 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 | — |
| +2 | K131966 | Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter… | Twin Star Medical, Inc. | 2014 | — |
| +3 | K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| +1 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2005 | Not classified | Z-0034-06 | Other | The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060963 (Twin Star Medical, 2006) has gone furthest, with 9 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.
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 | — |
https://510kreport.com/device/K844214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844214: Compartment Syndrome Pressure Monitor Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844214
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026