Company
Nipro Renal Soultions USA, Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
6recalls (4 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation Citric Complete Liquid Citric Acid Concentrate
REF: LC+200-D,LC+201, LC+225(45X) Open, Classified |
KPO | K223431 |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation Citric Complete Dry Citric Acid Concentrate
REF: DCA+200-25 & DCA+203-25 Open, Classified |
KPO | K171750 |
| 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 | K131202 |
| Sep 10, 2026 | Nipro Renal Soultions USA, Corporation MedicaLyte Liquid Bicarbonate Concentrate
REF: BC-100 and BC+201 Open, Classified |
KPO | K012547 |
| May 14, 2025 | Nipro Renal Soultions USA, Corporation MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X.
Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). Open, Classified |
KPO | K012547 |
| Jan 8, 2025 | Nipro Renal Soultions USA, Corporation Citric Complete - Dry Citric Acid Concentrate
Model Number: DCA+225-25 Open, Classified |
KPO | K171750 |