Hemodialysis Concentrate, Sodiu
FDA 510(k) K781967 · Renal Systems, Inc.
510(k) numberK781967
Submission
- Device name
- Hemodialysis Concentrate, Sodiu
- Applicant
- Renal Systems, Inc.
Mchenry, IL, US - Received
- November 24, 1978
- Decision date
- December 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPO – Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260799 | Nipro Dry Acid Concentrate MixerKPO · Traditional | Nipro Technical Solutions, Incoporated | 08/19/2026SE |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 01/29/2026SE |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/09/2025SE |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/04/2025SE |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS)KPO · Traditional | Deka Research and Development | 07/12/2024SE |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW…KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/10/2024SE |
| K233213 | NxStage PureFlow SolutionKPO · Traditional | Nxstage Medical, Inc. | 01/18/2024SE |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/01/2023SE |
| K223431 | Citric Complete Liquid Citric Acid ConcentrateKPO · Traditional | Nipro Renal Solutions USA, Corp. | 08/04/2023SE |
| K221652 | NikkicartKPO · Traditional | Renal Care Dialysis Solutions, S.A. DE C.V. | 03/03/2023SE |
More from Renal Care Dialysis Solutions, S.A. DE C.V.
| 510(k) | Device | Decision |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844790 | Renaflo HemoconcentratorKDI · Traditional | 05/23/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
Questions and answers
When was Hemodialysis Concentrate, Sodiu cleared by the FDA?
Hemodialysis Concentrate, Sodiu (K781967) received a 510(k) decision of Substantially Equivalent on December 7, 1978, 13 days after the submission was received.
What is the product code of K781967?
The FDA product code is KPO – Dialysate Concentrate For Hemodialysis (Liquid Or Powder), a Class II (moderate risk) device regulated under 21 CFR 876.5820.