FDA.report

510(k) K240920

Device
HemoCare Bicarbonate Concentrate Set (BCS)
Applicant
Deka Research and Development
510(k) number
K240920
Product code
KPO
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-12
Date received
2024-04-04
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

Related Records

Applicant Contact

Contact
Paul Smolenski
Address
340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KPO

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
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
K221652NIKKICARTRenal Care Dialysis Solutions, S.A. DE C.V.2023-03-03
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