Data / Medical devices / United States / KX Medical, Inc.
KX Medical, Inc.: FDA-registered device maker in Gallatin, TN, United States, 1 510(k) clearance
KX Medical, Inc. is registered with the FDA (registration 3026544741) in Gallatin, TN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 7, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026544741
- Address
- 110 Caroline Way, Gallatin, TN, United States, 37066
- Owner or operator
- KX Medical, Inc. (10087425)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 26, 2023
- Registered through
- 2026
- Brand names listed
- Procellera Antimicrobial Wound Dressing, Procellera Composite Antibacterial Wound Dressing, SomniFix Sleep Therapy, Thoroseal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Nasal | LWF | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer | 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 7, 2016 | K160783 | Procellera | FRO | Substantially Equivalent | Vomaris Innovations, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Nasal
- All makers of Dressing, Wound, Occlusive
- All makers of Dressing, Wound, Drug
Updated September 7, 2016. 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.