Data / Medical devices / Dialysate Concentrate For Hemodialysis (Liquid Or Powder) / United States
FDA-registered makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder) in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (product code KPO). 12 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.
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- Device
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Product code
- KPO
- Country
- United States
Makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 10 | January 29, 2026 | 0 | 25 | 2 | api.fda.gov |
| Di-Chem, Inc. | Champlin, MN, United States | Contract manufacturer, Manufacturer, Specification developer | 6 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Diasol Inc | Phoenix, AZ, United States | Manufacturer | 5 | February 10, 2014 | 0 | 3 | 0 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Irving, TX, United States | Manufacturer | 5 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nipro Renal Solutions USA, Corporation | Lewisberry, PA, United States | Manufacturer | 5 | August 4, 2023 | 0 | 3 | 1 | api.fda.gov |
| Rockwell Medical | Grapevine, TX, United States | Complaint file establishment, Manufacturer | 5 | March 3, 2023 | 0 | 2 | 0 | api.fda.gov |
| Rockwell Medical | Wixom, MI, United States | Complaint file establishment, Manufacturer | 5 | March 3, 2023 | 0 | 1 | 0 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Oregon, OH, United States | Manufacturer | 4 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 3 | January 18, 2024 | 0 | 7 | 0 | api.fda.gov |
| Isopure, Corp. | Louisville, KY, United States | Manufacturer | 2 | January 22, 2020 | 0 | 3 | 0 | api.fda.gov |
| Rockwell Medical | Washington, IA, United States | Manufacturer | 2 | January 3, 2003 | 0 | 0 | 0 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Knoxville, TN, United States | Manufacturer, Specification developer | 1 | May 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Evoqua Water Technologies LLC | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.