510(k) K131202 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
| Applicant | Dialysis Medical Solutions, LLC, Columbus OH, US |
| Decision | Substantially Equivalent, Apr 3, 2014 |
| Received | Apr 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation MedicaLyte Bicarbonate Powder
REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) Open, Classified |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.