510(k) K212620 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, May 12, 2022 |
| Received | Aug 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Open, Classified |
KPO | None listed |
| Sep 3, 2026 | Fresenius Medical Care Renal Therapies Group, LLC Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis Open, Classified |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.