Data / Medical devices / United States / KCI NORTH IX (Technical Services Center)
KCI NORTH IX (Technical Services Center): FDA-registered device maker in San Antonio, TX, United States, 4 510(k) clearances
KCI NORTH IX (Technical Services Center) is registered with the FDA (registration 3014209526) in San Antonio, TX, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 13, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014209526
- Address
- 5850 Farinon Dr., San Antonio, TX, United States, 78249
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Manufacturer
- First device listed
- October 31, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Negative Pressure Wound Therapy Device For Reduction Of Wound Complications | QFC | 2 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | 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 |
|---|---|---|---|---|---|---|
| February 13, 2023 | K223263 | Prevena Plus 125 Therapy Unit | QFC | Substantially Equivalent | 3M | accessdata.fda.gov |
| July 8, 2020 | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Kci USA, Inc. | accessdata.fda.gov |
| December 9, 2016 | K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | Kci USA, Inc. | accessdata.fda.gov |
| May 31, 2012 | K120033 | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT | OMP | Substantially Equivalent | Kci USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Updated February 13, 2023. 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.