FDA.reportPublic FDA data

510(k) K221652

Device
NIKKICART
Applicant
Renal Care Dialysis Solutions, S.A. DE C.V.
510(k) number
K221652
Product code
KPO
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-03
Date received
2022-06-07
Regulation
876.5820
Classification name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jose Enrique Aguirre Valades
Address
Carretera A Los Cues K.M. 2.2, Lote 23, Bodegas 5 Y 6, Parque Tecnologico Innovacion Queretaro El Marques MX 76246 76246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC2026-01-29
K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLC2025-09-09
K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLC2025-04-04
K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development2024-07-12
K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC2024-05-10
K233213NxStage PureFlow SolutionNxstage Medical, Inc.2024-01-18
K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC2023-12-01
K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.2023-08-04
K202508Hemo-Lyte C CartridgeDi-Chem, Inc.2022-08-12
K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC2022-05-12
K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L.2021-07-23
K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.2020-11-25
K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC2020-05-08
K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC2020-04-24
K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)Fresenius Medical Care Renal Therapies Group, LLC2020-02-24