Nikkicart
FDA 510(k) K221652 · Renal Care Dialysis Solutions, S.A. DE C.V.
510(k) numberK221652
Submission
- Device name
- Nikkicart
- Applicant
- Renal Care Dialysis Solutions, S.A. DE C.V.
El Marques, MX - Received
- June 7, 2022
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K202508 | Hemo-Lyte C CartridgeKPO · Traditional | Di-Chem, Inc. | 08/12/2022SE |
Questions and answers
When was Nikkicart cleared by the FDA?
Nikkicart (K221652) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 269 days after the submission was received.
What is the product code of K221652?
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.