Data / Medical devices / Set, Administration, For Peritoneal Dialysis, Disposable
Set, Administration, For Peritoneal Dialysis, Disposable (KDJ): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ, Class 2, 21 CFR 876.5630). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 113 510(k) clearances under this code, the latest on April 3, 2025, and lists 17 recall events (2 Class I). FDA data exported November 2, 2026.
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- Product code
- KDJ
- Device class
- 2
- Regulation
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Mexico | 3 |
| India | 1 |
| Ireland | 1 |
| Pakistan | 1 |
| Germany | 1 |
Makers of Set, Administration, For Peritoneal Dialysis, Disposable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 6 | April 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 6 | April 3, 2025 | 0 | 0 | 0 | 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 |
| Vantive Healthcare Technologies Private Limited | Bangalore Karnataka, India | Specification developer | 3 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Vantive Manufacturing Limited | SWINFORD Mayo, Ireland | Manufacturer | 2 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Baxter S.A. De C.V. | Civac, Jiutepec, Morelos, Mexico | Manufacturer | 1 | October 29, 2015 | 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 | |
| Byonyks Pvt Ltd | Lahore Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Deutschland GMBH | ST. WENDEL Saarland, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 3, 2025. 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.