510(k) K233950 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 10, 2024 |
| Received | Dec 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233950
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.