510(k) K253462 · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 29, 2026 |
| Received | Oct 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253462
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.