Data / Medical devices / Monitor, Pressure, Intracompartmental
Monitor, Pressure, Intracompartmental (LXC): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Monitor, Pressure, Intracompartmental (product code LXC, Class U). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 16, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LXC
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Switzerland | 2 |
| Canada | 1 |
Makers of Monitor, Pressure, Intracompartmental
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| C2Dx, Inc. | Schoolcraft, MI, United States | Complaint file establishment, Specification developer | 1 | April 4, 1985 | 0 | 0 | 0 | api.fda.gov |
| Compremium AG | Muri Bern, Switzerland | Complaint file establishment, Specification developer | 1 | April 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| My01, Inc. | Montreal Quebec, Canada | Manufacturer | 1 | March 13, 2025 | 0 | 1 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | July 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Specification developer | 1 | July 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Interson Corp. | Pleasanton, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.