Data / Medical devices / United States / Sentinel Medical Technologies, LLC
Sentinel Medical Technologies, LLC: FDA-registered device maker in Jacksonville, FL, United States, 3 510(k) clearances
Sentinel Medical Technologies, LLC is registered with the FDA (registration 3021468326) in Jacksonville, FL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021468326
- Address
- 50 N Laura St Ste 2500, Jacksonville, FL, United States, 32202
- Owner or operator
- Sentinel Medical Technologies, LLC (10083817)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 21, 2021
- Registered through
- 2026
- Brand names listed
- TraumaGuard Cable GE, 000-0260, TraumaGuard Cable Philips, 000-0250, TraumaGuard Cable Universal, 000-0229, TraumaGuard GE-Carescape Cable, 000-0320, TraumaGuard Intra Abdominal Pressure Monitoring System, TraumaGuard Intra-abdominal Pressure Monitoring System, TraumaGuard Intra-abdominal Pressure System Catheter, 000-0221, TraumaGuard MindRay Cable, 000-0330 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intra-Abdominal Pressure Monitoring Device | PHU | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2026 | K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | EZL | Substantially Equivalent | Sentinel Medical Technologies, | accessdata.fda.gov |
| April 17, 2024 | K240057 | TraumaGuard Intra-abdominal Pressure Sensing System | EZL | Substantially Equivalent | Sentinel Medical Technologies, LLC | accessdata.fda.gov |
| October 29, 2021 | K210570 | TraumaGuard Intra-abdominal Pressure Sensing System | PHU | Substantially Equivalent | Sentinel Medical Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Intra-Abdominal Pressure Monitoring Device
- All makers of Catheter, Retention Type, Balloon
Updated September 4, 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.