Data / Medical devices / United States / Fresenius USA Manufacturing, Inc.
Fresenius USA Manufacturing, Inc.: FDA-registered device maker in Irving, TX, United States, 5 510(k) clearances
Fresenius USA Manufacturing, Inc. is registered with the FDA (registration 1651896) in Irving, TX, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1651896
- FEI number
- 3003310249
- Address
- 5201 Regent Blvd, Irving, TX, United States, 75063
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Manufacturer
- First device listed
- March 2, 2020
- Registered through
- 2026
- Brand names listed
- Citrasate Dry Acid Concentrate, Citrasate Liquid Acid Concentrate, Granuflo Dry Acid Concentrate, NaturaLyte Dry Bicarbonate (08-4112-2), NaturaLyte Dry Bicarbonate Concentrate, NaturaLyte Liquid Acid Concentrate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| January 29, 2026 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 12, 2022 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 8, 2020 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 24, 2020 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 24, 2020 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
Compare with other makers
Updated January 29, 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.