Fresenius Medical Care Renal Therapies Group, LLC · Class II · Cleared Jan 29, 2026
| K-number | K253462 |
| Device name | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC |
| Product code | KPO |
| Device class | Class II |
| Decision date | Jan 29, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.5820 |
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is a non-sterile, single-use powder composed of USP-grade sodium bicarbonate supplied in a 7807 g bag that yields 25.36 gallons of bicarbonate concentrate. It is mixed with water and used as one component in preparing dialysate for 3-stream proportioning hemodialysis machines to treat acute and chronic renal failure by creating an osmotic gradient across the dialyzer membrane.
The device has identical intended use, indications for use, design, materials, principle of operation, and performance requirements to the predicate device (K191474). It consists of dry sodium bicarbonate in a 9-layered coextruded film bag (external nylon layer with polyolefin and nylon internal layers and LLDPE seal layer) and proportions a nominal 1:1.72:42.28 ratio (acid:bicarbonate:water) for 45X proportioning systems.
Testing followed ISO 10993-1:2018 for biocompatibility, ASTM D4169-22 for shipping and distribution verification, ISO Guinea Pig Sensitization Maximization for sensitization, ISO Intracutaneous Irritation testing, USP Pyrogen Study for pyrogenicity, and ASTM Hemolysis Extract for hemocompatibility. Stability evaluations supported a 3-month shelf life.
View the full FDA submission: accessdata.fda.gov