Product code KDI

Device name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5860
Review panel: GU
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252377	NxStage System One with NxView	Fresenius Medical Care Renal Therapies Group, LLC	2026-05-15
K260533	ELISIO™-H	Nipro Medical Corporation	2026-03-19
K252459	multiFlux 130 (F00013123); multiFlux 160 (F00013124)	Fresenius Medical Care Renal Therapies Group, LLC	2026-02-10
K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)	Outset Medical, Inc.	2026-01-26
K253518	FX CorAL 40; FX CorAL 50	Fresenius Medical Care Renal Therapies Group, LLC	2025-12-18
K243920	Purema H Hemoconcentrator - Pediatric	Medica USA, Inc.	2025-09-19
K250508	AK 98 Dialysis Machine (955607)	Vantive US Healthcare, LLC	2025-08-01
K243237	2008T 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, LLC	2025-06-13
K243505	5008X Hemodialysis System	Fresenius Medical Care Renal Therapies Group, LLC	2025-05-30
K242155	DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)	NIKKISO CO., LTD.	2025-05-15
K243264	DHF 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
K242053	FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)	Fresenius Medical Care Renal Therapies Group, LLC	2025-03-21
K243874	FX 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, LLC	2025-02-28
K233798	Moda-flx Hemodialysis System and Cartridge	Diality, Inc.	2024-08-02
K233557	HemoCare Hemodialysis System	Deka Research and Development	2024-07-12
K240394	multiFlux 1000 (F00012408)	Fresenius Medical Care Renal Therapies Group, LLC	2024-05-31
K232776	Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer	Outset Medical, Inc.	2024-05-03
K232803	NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)	Nxstage Medical, Inc.	2024-03-14
K232171	Purema® H Hemoconcentrator (EtO Sterilized)	Tecnoideal America	2024-02-07
K231534	5008X Hemodialysis System	Fresenius Medical Care	2024-02-02
K231125	2008T BlueStar Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	2023-12-06
K233335	Tablo® Hemodialysis System	Outset Medical, Inc.	2023-12-05
K232467	CleanCart A, CleanCart C, AK 98 Hemodialysis Machine	Baxter Healthcare Corporation	2023-09-14
K230632	VersiHD with GuideMe software	Nxstage Medical, Inc.	2023-08-11
K223248	Tablo® Hemodialysis System	Outset Medical, Inc.	2023-06-21
K231406	ClearumTM HS	Bellco Srl	2023-06-14
K220721	FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000	Fresenius Medical Care Renal Therapies Group, LLC	2023-05-11
K220281	multiFiltratePRO System	Fresenius Medical Care Renal Therapies Group, LLC	2022-12-16
K222067	SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set	Quanta Dialysis Technologies, Ltd.	2022-11-10
K222952	2008T BlueStar Hemodailysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	2022-10-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08056992333628	HPH JUNIOR	MEDICA SPA	2026-04-01
08056992333611	HPH-1400TS HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333543	HPH-700 HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333550	HPH-700TS HEMOCONCENTRAT	MEDICA SPA	2026-04-01
08056992333567	HPH-400 HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333574	HPH-1000 HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333581	HPH-1400 HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333598	HPH-400TS HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08056992333604	HPH-1000TS HEMOCONCENTRATOR	MEDICA SPA	2026-04-01
08051736007049	CLEARUM HS	Mozarc Medical US LLC	2023-08-04
08051736004130	CLEARUM HS	BELLCO SRL	2021-01-01
08051736004147	CLEARUM HS	BELLCO SRL	2021-01-01
08051736004154	CLEARUM HS	BELLCO SRL	2021-01-01
08051736004161	CLEARUM HS	BELLCO SRL	2021-01-01
08051736004178	CLEARUM HS	BELLCO SRL	2021-01-01
M535CAR5020	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-02
M535CAR5000	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR5050	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR172WW0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR172C0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR1720	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR171C0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR171B0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR170C0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR170B0	NXSTAGE CARTRIDGE EXPRESS	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR125B0	NXSTAGE CARTRIDGE	NXSTAGE MEDICAL, INC.	2015-09-01
M535CAR124C0	NXSTAGE CARTRIDGE	NXSTAGE MEDICAL, INC.	2015-09-01
08033178233637	SH	SORIN GROUP ITALIA SRL	2015-07-15
08033178102940	DHF	SORIN GROUP ITALIA SRL	2015-07-15
08033178102933	DHF	SORIN GROUP ITALIA SRL	2015-07-15

Product code KDI

Related 510(k) Records#

Related GUDID Devices#