510(k) K231534 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
5008X Hemodialysis System
| Applicant | Fresenius Medical Care, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 2, 2024 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2025 | Fresenius Medical Care Holdings, Inc. 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models:
a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7.
b. 5008X Standard HDF Bloodline w/CLIC, Model Number: Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.