FDA.reportPublic FDA data

510(k) K233159

Device
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
510(k) number
K233159
Product code
KPO
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-01
Date received
2023-09-27
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
Timothy Groves
Address
920 Winter St. Waltham MA US 02451 02451

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
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