Dialyzer, High Permeability With Or Without Sealed Dialysate System

KDI 2026-05-15

NxStage System One with NxView

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K252377

KDI 2026-03-19

ELISIO™-H

K number K260533

KDI 2026-02-10

multiFlux 130 (F00013123); multiFlux 160 (F00013124)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K252459

KDI 2026-01-26

Tablo Hemodialysis System (PN-0008000, PN-0006000U)

Applicant Outset Medical, Inc.

K number K253412

KDI 2025-12-18

FX CorAL 40; FX CorAL 50

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K253518

KDI 2025-09-19

Purema H Hemoconcentrator - Pediatric

Applicant Medica USA, Inc.

K number K243920

KDI 2025-08-01

AK 98 Dialysis Machine (955607)

Applicant Vantive US Healthcare, LLC

K number K250508

KDI 2025-06-13

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)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K243237

KDI 2025-05-30

5008X Hemodialysis System

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K243505

KDI 2025-05-15

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

Applicant NIKKISO CO., LTD.

K number K242155

KDI 2025-04-25

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Applicant Sorin Group Italia S.R.L.

K number K243264

KDI 2025-03-21

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K242053

KDI 2025-02-28

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)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K243874

KDI 2024-08-02

Moda-flx Hemodialysis System and Cartridge

Applicant Diality, Inc.

K number K233798

KDI 2024-07-12

HemoCare Hemodialysis System

Applicant Deka Research and Development

K number K233557

KDI 2024-05-31

multiFlux 1000 (F00012408)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K240394

KDI 2024-05-03

Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer

Applicant Outset Medical, Inc.

K number K232776

KDI 2024-03-14

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)

Applicant Nxstage Medical, Inc.

K number K232803

KDI 2024-02-07

Purema® H Hemoconcentrator (EtO Sterilized)

Applicant Tecnoideal America

K number K232171

KDI 2024-02-02

5008X Hemodialysis System

Applicant Fresenius Medical Care

K number K231534

KDI 2023-12-06

2008T BlueStar Hemodialysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K231125

KDI 2023-12-05

Tablo® Hemodialysis System

Applicant Outset Medical, Inc.

K number K233335

KDI 2023-09-14

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

K number K232467

KDI 2023-08-11

VersiHD with GuideMe software

Applicant Nxstage Medical, Inc.

K number K230632

KDI 2023-06-21

Tablo® Hemodialysis System

Applicant Outset Medical, Inc.

K number K223248

KDI 2023-06-14

ClearumTM HS

Applicant Bellco Srl

K number K231406

KDI 2023-05-11

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K220721

KDI 2022-12-16

multiFiltratePRO System

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K220281

KDI 2022-11-10

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Applicant Quanta Dialysis Technologies, Ltd.

K number K222067

KDI 2022-10-27

2008T BlueStar Hemodailysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K222952

KDI 2022-07-29

Tablo Hemodialysis System

Applicant Outset Medical, Inc.

K number K211370

KDI 2022-05-13

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

Applicant Nephros

K number K210575

KDI 2022-04-01

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

K number K212216

KDI 2022-01-24

Revaclear 500, Revaclear 400, Revaclear 300

K number K213639

KDI 2021-08-12

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Applicant Quanta Dialysis Technologies, Ltd.

K number K210661

KDI 2021-03-10

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

Applicant Baxter Healthcare Corportation

K number K201809

KDI 2020-12-28

Optiflux Series of Dialyzers F160NR, F180NR, F200NR

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K203062

KDI 2020-12-23

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Applicant Quanta Dialysis Technologies, Ltd.

K number K193670

KDI 2020-10-08

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

Applicant Bellco Srl

K number K193542

KDI 2020-09-21

Optiflux F180NR Dialyzer

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K192707

KDI 2020-08-28

DIMI RRT System

Applicant Dialco Medical, Inc.

K number K193005

KDI 2020-07-09

Optiflux Enexa F500 Dialyzer

Applicant Fresenius Medical Care Reanal Therapies Group, LLC

K number K192928

KDI 2020-03-31

Tablo Hemodialysis System

Applicant Outset Medical, Inc.

K number K200741

KDI 2020-03-13

PrisMax System Version 3

K number K193482

KDI 2020-02-24

Aquadex FlexFlow System 2.0

Applicant Chf Solutions, Inc.

K number K192756

KDI 2019-12-12

Tablo Hemodialysis System, Tablo Cartridge

Applicant Outset Medical, Inc.

K number K190793

KDI 2019-08-09

NxStage Cartridge Express with Speedswap

Applicant Nxstage Medical, Inc.

K number K183158

KDI 2019-07-25

PrisMax System Version 2

Applicant Baxter Healthcare Corp

K number K190910

KDI 2019-07-19

Surdial DX Hemodialysis System

K number K182940

KDI 2018-05-10

2008T BlueStar Hemodialysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K173972

KDI 2018-02-23

Prismaflex System 8.10

K number K171671

KDI 2017-12-13

SAM CRRT Unit, SAM Cassette CRRT

Applicant Spectral Medical, Inc.

K number K170790

KDI 2017-08-24

NxStage System One

Applicant Nxstage Medical, Inc.

K number K171331

KDI 2017-08-11

Diacap Pro Dialyzer

Applicant B. Braun Avitum AG

K number K170574

KDI 2017-05-09

NxStage System One Plus

Applicant Nxstage Medical, Inc.

K number K170469

KDI 2017-05-03

PrisMax Control Unit

Applicant Baxter Healthcare Corp

K number K163530

KDI 2017-05-03

Asahi ViE-U Series Dialyzer

Applicant Asahi Kasei Medical Co., Ltd.

K number K162248

KDI 2017-04-06

Optiflux dialyzer

K number K162488

KDI 2017-02-08

FB-U Hemodialyzer

K number K160444

KDI 2016-11-18

RAPIDO HOLLOW-FIBRE DIALYZERS

Applicant Bellco Srl

K number K160558

KDI 2016-11-15

Tablo Console

Applicant Outset Medical, Inc.

K number K160881

KDI 2016-04-26

2008K2 Hemodialysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K153449

KDI 2016-03-18

DBB-06 Hemodialysis Delivery System

Applicant NIKKISO CO., LTD.

K number K152938

KDI 2016-03-01

xevonta dialyzer

Applicant B. Braun Avitum AG

K number K143482

KDI 2013-12-27

NXSTAGE 1.6M2 DIALYZER

Applicant Nxstage Medical, Inc.

K number K131050

KDI 2013-12-20

ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER

K number K131935

KDI 2013-12-19

ELISIO-H HEMODIALYZER

K number K131381

KDI 2013-10-11

2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K131908

KDI 2013-06-26

HEMOCONCENTRATOR

Applicant Maquet Cardiopulmonary, AG

K number K123288

KDI 2013-05-07

PUREFLUX-H HEMODIALYZER

K number K122343

KDI 2013-05-02

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

Applicant Gambro Renal Products, Inc.

K number K130039

KDI 2013-05-01

ELISIO-H AND ELISIO-M HEMODIALYZERS

K number K122347

KDI 2013-04-23

NXSTAGE SYSTEM ONE

Applicant Nxstage Medical, Inc.

K number K122051

KDI 2013-03-07

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Applicant Nxstage Medical, Inc.

K number K123395

KDI 2013-02-06

ASAHI REXEED-SX/LX SERIES DIALYZER

Applicant Asahi Kasei Medical Co., Ltd.

K number K121409

KDI 2012-12-21

STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER

Applicant Nxstage Medical, Inc.

K number K113023

KDI 2012-12-06

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM

K number K121341

KDI 2012-08-17

VENOFER PUMP

Applicant Renal Solutions, Inc.

K number K121497

KDI 2012-04-27

NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER

Applicant Nephros, Inc.

K number K112314

KDI 2012-03-06

FRESENIUS 2008T HEMODIALYSIS MACHINE

Applicant Fresenius Medical Care North America, Design Cente

K number K120505

KDI 2012-02-02

FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM

K number K120017

KDI 2011-12-21

FRESENIUS 2008T HEMODIALYSIS MACHINE

K number K113427

KDI 2011-10-21

FRESENIUS 2008T HEMODIALYSIS MACHINE

Applicant Fresenius Medical Care

K number K111639

KDI 2011-06-17

PRISMAFLEX

Applicant Gambro Renal Products, Inc.

K number K110823

KDI 2011-05-20

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

Applicant Gambro Renal Products, Inc.

K number K103832

KDI 2011-02-10

VENOFER PUMP

Applicant Renal Solutions, Inc.

K number K103564

KDI 2010-12-21

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

Applicant Fresenius Medical Care North America, Design Cente

K number K101715

KDI 2010-10-23

NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE

Applicant Nxstage Medical, Inc.

K number K093069

KDI 2010-07-09

VENOFER PUMP

Applicant Renal Solutions, Inc.

K number K093964

KDI 2010-05-27

MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573

K number K093902

KDI 2010-04-22

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811

Applicant B. Braun Avitum AG

K number K100334

KDI 2010-03-25

DBB-06 HEMODIALYSIS DELIVERY SYSTEM

Applicant NIKKISO CO., LTD.

K number K091978

KDI 2010-02-18

DIALOG WITH ADIMEA OPTION

Applicant B. Braun Avitum AG

K number K083460

KDI 2010-02-17

XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170

Applicant Baxter Healthcare Corporation - Renal Division

K number K093120

KDI 2010-02-09

TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM

Applicant Bl Healthcare, Inc.

K number K093379

KDI 2009-11-19

EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00

Applicant Edwards Lifesciences Services GmbH

K number K090682

KDI 2009-06-05

EXALIS, SOFTWARE VERSION 1.15

Applicant Gambro, Inc.

K number K083158

KDI 2009-02-20

XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210

K number K083778

KDI 2009-01-14

FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE

K number K080964