510(k) · Cleared
ClearedCompremium Compartment Compressibility Monitoring System (CPM#1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compremium AG · LXC Monitor, Pressure, Intracompartmental
Cleared on Apr 14, 2023 as substantially equivalent to K210525 (MY01, Inc., 2021) after a 143-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Apr 14, 2023
- Review
- 143 days
- Class
- Class U
- Product code
- LXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844214 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK844214 Compartment Syndrome Pressure Monitor SysStryker Corp. · 1985 · Recalled
- 6 generations backK060963 Twin Star Compartment Pressure Monitoring and Fluid Collection…Twin Star Medical · 2006
- 5 generations backK090961 Twin Star Compartment Pressure Monitor and Fluid Collection Catheter…Twin Star Medical, Inc. · 2009
- 4 generations backK131966 Twin Star Extremity Compartment Syndrome Monitor and Fluid…Twin Star Medical, Inc. · 2014
- 3 generations backK193321 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 2 generations backK202635 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2020
- 1 generation backK210525 MY01 Continuous Compartmental Pressure MonitorMY01, Inc. · 2021 · Recalled
- This deviceK223509 Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844214 | Compartment Syndrome Pressure Monitor Sys | Stryker Corp. | 1985 | 1 |
| −6 | K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS… | Twin Star Medical | 2006 | — |
| −5 | K090961 | Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System… | Twin Star Medical, Inc. | 2009 | — |
| −4 | 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 | — |
| −2 | K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020 | — |
| −1 | K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021 | 1 |
| 0 (this device) | K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | Compremium AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K210525 | MY01 Continuous Compartmental Pressure MonitorSummary page 4…l Orthopedic Classification Pre-amendment, Unclassified Product Code(s) LXC Predicate Device MY01 Continuous Compartmental Pressure Monitor (K210525) Reference Device Interson USB Ultrasound System (K163443) The Compartmental Compressibility Mon… | 2021 |
| † | K163443 | Interson USB Ultrasound System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K210525.
How does its category compare?
All LXC devicesLXC Monitor, Pressure, Intracompartmental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Compartmental Compressibility Monitoring System (CPM#1) is intended for real-time and intermittent monitoring of
relative compartment compressibility.
The relative compartment compressibility (CP Value) is not meant for trend analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223509: Compremium Compartment Compressibility Monitoring System (CPM#1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223509
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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