Monitor, Pressure, Intracompartmental
The Intracompartmental Pressure Monitor (product code LXC) is a device used to measure tissue pressure within muscle compartments, aiding in the diagnosis of acute compartment syndrome, a potentially limb-threatening condition requiring urgent surgical intervention. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Orthopedic (OR) panel. As an unclassified device, its regulatory pathway has not been fully determined. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- LXC
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242997 | MY01 Continuous Compartmental Pressure Monitor | Mar 13, 2025 | Substantially Equivalent | MY01 Inc. |
| K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | Apr 14, 2023 | Substantially Equivalent | Compremium AG |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | May 24, 2022 | Substantially Equivalent | MY01 Inc. |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | Apr 22, 2021 | Substantially Equivalent | MY01 Inc. |
| K202635 | MY01 Continuous Compartmental Pressure Monitor | Dec 10, 2020 | Substantially Equivalent | MY01, Inc. |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | Jul 30, 2020 | Substantially Equivalent | MY01, Inc. |
| K131966 | TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM | Feb 07, 2014 | Substantially Equivalent | TWIN STAR MEDICAL, INC. |
| K090961 | TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) | Jun 12, 2009 | Substantially Equivalent | TWIN STAR MEDICAL, INC. |
| K060963 | TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) | Jun 06, 2006 | Substantially Equivalent | TWIN STAR MEDICAL |
| K041771 | TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM | Sep 14, 2004 | Substantially Equivalent | TWIN STAR MEDICAL, INC. |
| K031555 | SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM | Jul 08, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K881858 | ACE ICPM SIDE PORTED NEEDLE | May 27, 1988 | Substantially Equivalent | BUCKMAN CO., INC. |
| K873684 | ACE INTRA COMPARTMENTAL PRESSURE MONITOR | Jan 20, 1988 | Substantially Equivalent | ACE MEDICAL CO. |
| K844214 | COMPARTMENT SYNDROME PRESSURE MONITOR SYS | Apr 04, 1985 | Substantially Equivalent | STRYKER CORP. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.