510(k) K243786 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243786
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Fresenius Medical Care Holdings, Inc. Bicarby Dialysate; Model number: RFP-400-G; Open, Classified |
KPO | None listed |
| Jun 5, 2026 | Fresenius Medical Care Holdings, Inc. Bicarby" Dialysate;
Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; Open, Classified |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.