Data / Medical devices / Dialyzer, Capillary, Hollow Fiber
Dialyzer, Capillary, Hollow Fiber (FJI): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Dialyzer, Capillary, Hollow Fiber (product code FJI, Class 2, 21 CFR 876.5820). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 131 510(k) clearances under this code, the latest on August 23, 2019, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FJI
- Device class
- 2
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 1 |
Makers of Dialyzer, Capillary, Hollow Fiber
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 | 1 | August 23, 2019 | 0 | 2 | 0 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Ogden, UT, United States | Manufacturer | 1 | August 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Gambro Dialysatoren GMBH | HECHINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | May 27, 2005 | 0 | 0 | 0 | api.fda.gov |
| Molded Products Inc. | Harlan, IA, United States | Manufacturer | 1 | November 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| Reprocessing Products Corporation (RPC) | Tucson, AZ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 30, 1995 | 0 | 0 | 0 | api.fda.gov |
Updated August 23, 2019. 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.