Data / Medical devices / Set, Administration, For Peritoneal Dialysis, Disposable / United States
FDA-registered makers of Set, Administration, For Peritoneal Dialysis, Disposable in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Set, Administration, For Peritoneal Dialysis, Disposable
- Product code
- KDJ
- Country
- United States
Makers of Set, Administration, For Peritoneal Dialysis, Disposable 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 | 7 | April 3, 2025 | 0 | 4 | 1 | api.fda.gov |
| Vantive US Healthcare LLC | Mountain Home, AR, United States | Manufacturer | 6 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gambro UF Solutions LLC | Plymouth, MN, United States | Specification developer | 4 | March 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Byonyks Medical Devices Inc | Itasca, IL, United States | Complaint file establishment, Specification developer | 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.