K191474 is an FDA 510(k) clearance for the NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton). This device is classified as a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II - Special Controls, product code KPO).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on February 24, 2020, 265 days after receiving the submission on June 4, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K191474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2019 |
| Decision Date | February 24, 2020 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |