510(k) K243505 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
5008X Hemodialysis System
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Nov 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X Standard HD Pre-Flush
Standard Blood Tubing Set
Part Number 03-5110-6 Open, Classified |
KOC | None listed |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF Standard Blood
Tubing Set
Part Number 03-5300-3 Open, Classified |
KOC | None listed |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with CLiC Blood
Tubing Set
Part number 03-5300-3C Open, Classified |
KOC | None listed |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group, LLC 5008X HD/HDF with Twister Blood
Tubing Set
Part Number 03-5350-8 Open, Classified |
KOC | None listed |
| Jul 8, 2026 | Fresenius Medical Care Holdings, Inc. 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions.
1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6.
2. 5008X HD/HDF Standard B Open, Classified |
KDI | None listed |
| Dec 17, 2025 | Fresenius Medical Care Holdings, Inc. 5008X CAREsystem +CLiC +CDX; Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.