FDA.reportPublic FDA data

510(k) K252377

Device
NxStage System One with NxView
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
510(k) number
K252377
Product code
KDI
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-15
Date received
2025-07-30
Regulation
876.5860
Classification name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Caitlin Kalda
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 KDI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260533ELISIO™-HNipro Medical Corporation2026-03-19
K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC2026-02-10
K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.2026-01-26
K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC2025-12-18
K243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.2025-09-19
K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC2025-08-01
K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)Fresenius Medical Care Renal Therapies Group, LLC2025-06-13
K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC2025-05-30
K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)NIKKISO CO., LTD.2025-05-15
K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)Sorin Group Italia S.R.L.2025-04-25
K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC2025-03-21
K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)Fresenius Medical Care Renal Therapies Group, LLC2025-02-28
K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.2024-08-02
K233557HemoCare Hemodialysis SystemDeka Research and Development2024-07-12
K240394multiFlux 1000 (F00012408)Fresenius Medical Care Renal Therapies Group, LLC2024-05-31