Data / Medical devices / United States / Fresenius USA Manufacturing, Inc.
Fresenius USA Manufacturing, Inc.: FDA-registered device maker in Knoxville, TN, United States, 1 510(k) clearance
Fresenius USA Manufacturing, Inc. is registered with the FDA (registration 3013546115) in Knoxville, TN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 18, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013546115
- Address
- 5105 South National Drive, Knoxville, TN, United States, 37914
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 15, 2017
- Registered through
- 2026
- Brand names listed
- bibag
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | 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 |
|---|---|---|---|---|---|---|
| May 18, 2017 | K162716 | bibag | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2017. 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.