510(k) K192209 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 8, 2020 |
| Received | Aug 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | None listed |
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine accordin Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.