Data / Medical devices / Dialyzer, High Permeability With Or Without Sealed Dialysate System / United States
FDA-registered makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI). 9 have a 510(k) clearance or PMA approval on file and 4 have a recall event. 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.
- Device
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Product code
- KDI
- Country
- United States
Makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System 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 | June 13, 2025 | 0 | 34 | 1 | api.fda.gov |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 10 | May 15, 2026 | 0 | 6 | 0 | api.fda.gov |
| Outset Medical, Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 7 | January 26, 2026 | 0 | 4 | 1 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Ogden, UT, United States | Manufacturer | 2 | September 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Gambro UF Solutions LLC | Plymouth, MN, United States | Specification developer | 2 | March 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nuwellis, Inc. | Eden Prairie, MN, United States | Manufacturer, Specification developer | 2 | February 24, 2020 | 0 | 1 | 1 | api.fda.gov |
| Diality, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Fresenius USA Manufacturing, Inc. | Oregon, OH, United States | Manufacturer | 1 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nephros, Inc. | South Orange, NJ, United States | Complaint file establishment, Specification developer | 1 | April 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kluge Design Inc. | Rogers, MN, United States | Contract 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.