Product Code: KDI FDA class 2 21 CFR 876.5860

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Gastroenterology, Urology

A high-permeability dialyzer, with or without a sealed dialysate system, is a kidney replacement therapy device that filters blood through a semipermeable membrane to remove uremic toxins, excess fluid, and electrolytes in patients with acute or chronic renal failure, using high-flux membranes for enhanced clearance of middle and large molecular weight solutes. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. Product code KDI is regulated under 21 CFR 876.5860 in the Gastroenterology, Urology medical specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in maintaining patient survival.

View on FDA

510(k)s

337

FEI Numbers

Registration Numbers

Unique Applicants

102

Years Active

Basic Information

Product Code: KDI
Device Class: FDA class 2
Regulation Number: 876.5860
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 337 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
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)	Jun 13, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K243505	5008X Hemodialysis System	May 30, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K242155	DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)	May 15, 2025	Substantially Equivalent	NIKKISO CO., LTD.
K243264	DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)	Apr 25, 2025	Substantially Equivalent	Sorin Group Italia S.r.l.
K242053	FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)	Mar 21, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
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)	Feb 28, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K233798	Moda-flx Hemodialysis System and Cartridge	Aug 02, 2024	Substantially Equivalent	Diality, Inc.
K233557	HemoCare Hemodialysis System	Jul 12, 2024	Substantially Equivalent	Deka Research and Development
K240394	multiFlux 1000 (F00012408)	May 31, 2024	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K232776	Tablo® Hemodialysis System; TabloCart with Prefiltration Drawer	May 03, 2024	Substantially Equivalent	Outset Medical, Inc.
K232803	NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)	Mar 14, 2024	Substantially Equivalent	NxStage Medical Inc.
K232171	Purema® H Hemoconcentrator (EtO Sterilized)	Feb 07, 2024	Substantially Equivalent	Tecnoideal America
K231534	5008X Hemodialysis System	Feb 02, 2024	Substantially Equivalent	Fresenius Medical Care
K231125	2008T BlueStar Hemodialysis Machine	Dec 06, 2023	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K233335	Tablo® Hemodialysis System	Dec 05, 2023	Substantially Equivalent	Outset Medical, Inc.
K232467	CleanCart A, CleanCart C, AK 98 Hemodialysis Machine	Sep 14, 2023	Substantially Equivalent	Baxter Healthcare Corporation
K230632	VersiHD with GuideMe software	Aug 11, 2023	Substantially Equivalent	NxStage Medical, Inc.
K223248	Tablo® Hemodialysis System	Jun 21, 2023	Substantially Equivalent	Outset Medical, Inc.
K231406	ClearumTM HS	Jun 14, 2023	Substantially Equivalent	Bellco Srl
K220721	FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000	May 11, 2023	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K220281	multiFiltratePRO System	Dec 16, 2022	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K222067	SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set	Nov 10, 2022	Substantially Equivalent	Quanta Dialysis Technologies Ltd
K222952	2008T BlueStar Hemodailysis Machine	Oct 27, 2022	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K211370	Tablo Hemodialysis System	Jul 29, 2022	Substantially Equivalent	Outset Medical, Inc.
K210575	HDF Assist Mudule, HDF Infusion Set and Substitution Filter	May 13, 2022	Substantially Equivalent	Nephros
K212216	Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set	Apr 01, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K213639	Revaclear 500, Revaclear 400, Revaclear 300	Jan 24, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K210661	SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset	Aug 12, 2021	Substantially Equivalent	Quanta Dialysis Technologies Ltd
K201809	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory	Mar 10, 2021	Substantially Equivalent	Baxter Healthcare Corportation
K203062	Optiflux Series of Dialyzers F160NR, F180NR, F200NR	Dec 28, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K193670	SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set	Dec 23, 2020	Substantially Equivalent	Quanta Dialysis Technologies Ltd.
K193542	Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22	Oct 08, 2020	Substantially Equivalent	Bellco Srl
K192707	Optiflux F180NR Dialyzer	Sep 21, 2020	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K193005	DIMI RRT System	Aug 28, 2020	Substantially Equivalent	Dialco Medical Inc.
K192928	Optiflux Enexa F500 Dialyzer	Jul 09, 2020	Substantially Equivalent	Fresenius Medical Care Reanal Therapies Group LLC
K200741	Tablo Hemodialysis System	Mar 31, 2020	Substantially Equivalent	Outset Medical, Inc.
K193482	PrisMax System Version 3	Mar 13, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K192756	Aquadex FlexFlow System 2.0	Feb 24, 2020	Substantially Equivalent	CHF Solutions, Inc.
K190793	Tablo Hemodialysis System, Tablo Cartridge	Dec 12, 2019	Substantially Equivalent	Outset Medical, Inc.
K183158	NxStage Cartridge Express with Speedswap	Aug 09, 2019	Substantially Equivalent	NxStage Medical, Inc.
K190910	PrisMax System Version 2	Jul 25, 2019	Substantially Equivalent	Baxter Healthcare Corp
K182940	Surdial DX Hemodialysis System	Jul 19, 2019	Substantially Equivalent	Nipro Medical Corporation
K173972	2008T BlueStar Hemodialysis Machine	May 10, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K171671	Prismaflex System 8.10	Feb 23, 2018	Substantially Equivalent	Baxter Healthcare Corporation
K170790	SAM CRRT Unit, SAM Cassette CRRT	Dec 13, 2017	Substantially Equivalent	Spectral Medical Inc.
K171331	NxStage System One	Aug 24, 2017	Substantially Equivalent	NxStage Medical, Inc.
K170574	Diacap Pro Dialyzer	Aug 11, 2017	Substantially Equivalent	B. Braun Avitum AG
K170469	NxStage System One Plus	May 09, 2017	Substantially Equivalent	NxStage Medical, Inc
K163530	PrisMax Control Unit	May 03, 2017	Substantially Equivalent	BAXTER HEALTHCARE CORP
K162248	Asahi ViE-U Series Dialyzer	May 03, 2017	Substantially Equivalent	ASAHI KASEI MEDICAL CO., LTD.
K162488	Optiflux dialyzer	Apr 06, 2017	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K160444	FB-U Hemodialyzer	Feb 08, 2017	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K160558	RAPIDO HOLLOW-FIBRE DIALYZERS	Nov 18, 2016	Substantially Equivalent	BELLCO Srl
K160881	Tablo Console	Nov 15, 2016	Substantially Equivalent	OUTSET MEDICAL, INC.
K153449	2008K2 Hemodialysis Machine	Apr 26, 2016	Substantially Equivalent	FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
K152938	DBB-06 Hemodialysis Delivery System	Mar 18, 2016	Substantially Equivalent	NIKKISO, CO.,LTD.
K143482	xevonta dialyzer	Mar 01, 2016	Substantially Equivalent	B. Braun Avitum AG
K153344	Asahi REXEED-S Series Dialyzer	Dec 17, 2015	Substantially Equivalent	Asahi Kasei Medical Co., Ltd.
K150708	2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine	Dec 10, 2015	Substantially Equivalent	FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
K152367	Optiflux dialyzer	Oct 29, 2015	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K150880	Tablo Console with Wireless Capability	May 01, 2015	Substantially Equivalent	Outset Medical
K143313	NxStage Therapeutic Plasma Exchange (TPE) Cartridge	Mar 20, 2015	Substantially Equivalent	NxStage Medical, Inc.
K140866	TABLO CONSOLE	Sep 10, 2014	Substantially Equivalent	HOME DIALYSIS PLUS
K133299	ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY	Jul 07, 2014	Substantially Equivalent	FRESENIUS MEDICAL CARE, NORTH AMERICA - RENAL THER
K140526	NXSTAGE SYSTEM ONE	May 19, 2014	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K140191	ELISIO-H HEMODIALYZER	Apr 14, 2014	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K133547	NXSTAGE SYSTEM ONE WITH NXVIEW	Mar 03, 2014	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K132602	STREAMLINE EXPRESS	Feb 04, 2014	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K123262	OPTIFLUX ULTRA DIALYZER	Jan 06, 2014	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K131516	PRISMAFLEX SYSTEM 7.10	Jan 03, 2014	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K131050	NXSTAGE 1.6M2 DIALYZER	Dec 27, 2013	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K131935	ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER	Dec 20, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K131381	ELISIO-H HEMODIALYZER	Dec 19, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K131908	2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)	Oct 11, 2013	Substantially Equivalent	FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
K123288	HEMOCONCENTRATOR	Jun 26, 2013	Substantially Equivalent	MAQUET CARDIOPULMONARY AG
K122343	PUREFLUX-H HEMODIALYZER	May 07, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K130039	REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER	May 02, 2013	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K122347	ELISIO-H AND ELISIO-M HEMODIALYZERS	May 01, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K122051	NXSTAGE SYSTEM ONE	Apr 23, 2013	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K123395	NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS	Mar 07, 2013	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K121409	ASAHI REXEED-SX/LX SERIES DIALYZER	Feb 06, 2013	Substantially Equivalent	ASAHI KASEI MEDICAL CO., LTD.
K113023	STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER	Dec 21, 2012	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K121341	FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM	Dec 06, 2012	Substantially Equivalent	FRESENIUS MEDICAL CARE, NORTH AMERICA
K121497	VENOFER PUMP	Aug 17, 2012	Substantially Equivalent	RENAL SOLUTIONS INC.
K112314	NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER	Apr 27, 2012	Substantially Equivalent	NEPHROS, INC.
K120505	FRESENIUS 2008T HEMODIALYSIS MACHINE	Mar 06, 2012	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K120017	FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM	Feb 02, 2012	Substantially Equivalent	FRESENIUS MEDICAL CARE, NORTH AMERICA
K113427	FRESENIUS 2008T HEMODIALYSIS MACHINE	Dec 21, 2011	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K111639	FRESENIUS 2008T HEMODIALYSIS MACHINE	Oct 21, 2011	Substantially Equivalent	FRESENIUS MEDICAL CARE
K110823	PRISMAFLEX	Jun 17, 2011	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K103832	PHOENIX HEMODIALYSIS DELIVERY SYSTEM	May 20, 2011	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K103564	VENOFER PUMP	Feb 10, 2011	Substantially Equivalent	RENAL SOLUTIONS, INC.
K101715	FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573	Dec 21, 2010	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K093069	NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE	Oct 23, 2010	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K093964	VENOFER PUMP	Jul 09, 2010	Substantially Equivalent	RENAL SOLUTIONS INC.
K093902	MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573	May 27, 2010	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K100334	DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811	Apr 22, 2010	Substantially Equivalent	B. BRAUN AVITUM AG
K091978	DBB-06 HEMODIALYSIS DELIVERY SYSTEM	Mar 25, 2010	Substantially Equivalent	NIKKISO CO. LTD.
K083460	DIALOG WITH ADIMEA OPTION	Feb 18, 2010	Substantially Equivalent	B. BRAUN AVITUM AG
K093120	XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170	Feb 17, 2010	Substantially Equivalent	BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
K093379	TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM	Feb 09, 2010	Substantially Equivalent	BL HEALTHCARE, INC.
K090682	EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00	Nov 19, 2009	Substantially Equivalent	EDWARDS LIFESCIENCES SERVICES GMBH
K083158	EXALIS, SOFTWARE VERSION 1.15	Jun 05, 2009	Substantially Equivalent	GAMBRO, INC.
K083778	XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210	Feb 20, 2009	Substantially Equivalent	BAXTER HEALTHCARE CORPORATION
K080964	FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE	Jan 14, 2009	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K080650	OMNI-DL SYSTEM	Nov 26, 2008	Substantially Equivalent	TRANSVIVO INC.
K081313	SH14 HEMOCONCENTRATOR	Nov 19, 2008	Substantially Equivalent	SORIN GROUP ITALIA S.R.L.
K082414	OPTIFLUX F250NR, MODEL 0500325E	Oct 28, 2008	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K082515	ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX	Oct 03, 2008	Substantially Equivalent	ASAHI KASEI MEDICAL CO., LTD.
K080519	PRISMAFLEX M150 SET	Jun 13, 2008	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K072093	PRISMAFLEX SYSTEM, VERSION 3.20	Feb 01, 2008	Substantially Equivalent	GAMBRO
K070643	PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35	Nov 02, 2007	Substantially Equivalent	GAMBRO, INC.
K061519	MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM	Sep 28, 2007	Substantially Equivalent	NIKKISO CO. LTD.
K072232	GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL	Sep 07, 2007	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K071854	AQUADEX FLEXFLOW SYSTEM	Sep 07, 2007	Substantially Equivalent	CHF SOLUTIONS, INC.
K071263	NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500	Aug 24, 2007	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K071518	DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS	Aug 17, 2007	Substantially Equivalent	B. BRAUN MEDIZINTECHNOLOGIE GMBH
K071298	HF JUNIOR HEMOFILTER	Aug 08, 2007	Substantially Equivalent	MINNTECH CORP.
K070320	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	Jun 07, 2007	Substantially Equivalent	EDWARDS LIFESCIENCES SERVICES GMBH
K070512	MODIFICATION TO AQUADEX FLEXFLOW SYSTEM	Apr 27, 2007	Substantially Equivalent	CHF SOLUTIONS, INC.
K070222	FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N	Apr 24, 2007	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K063183	PRISMA M10 PRE SET	Feb 15, 2007	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K062922	MODIFICATION TO AQUADEX FLEXFLOW SYSTEM	Dec 13, 2006	Substantially Equivalent	CHF SOLUTIONS, INC.
K062079	XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210	Oct 19, 2006	Substantially Equivalent	BAXTER HEALTHCARE CORPORATION
K062090	PRISMA SYSTEM R03.10A	Oct 18, 2006	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K061837	NXSTAGE CARTRIDGE EXPRESS	Jul 31, 2006	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K053539	MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576	May 24, 2006	Substantially Equivalent	BAXTER HEALTHCARE CORPORATION
K060195	GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE	Apr 24, 2006	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K060008	AQUADEX FLEXFLOW SYSTEM	Feb 02, 2006	Substantially Equivalent	CHF SOLUTIONS, INC.
K050952	HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR	Jan 31, 2006	Substantially Equivalent	MINNTECH CORP.
K051520	GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H	Dec 09, 2005	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K050609	AQUADEX SYSTEM	Nov 09, 2005	Substantially Equivalent	CHF SOLUTIONS, INC.
K050525	NXSTAGE SYSTEM ONE	Jun 24, 2005	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K050727	MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS	Jun 13, 2005	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K050603	OLPUR DIALYZER, MODEL HD 190	Jun 09, 2005	Substantially Equivalent	NEPHROS, INC.
K051187	REXEED SERIES DIALYZERS	Jun 08, 2005	Substantially Equivalent	ASAHI KASEI MEDICAL CO., LTD.
K042938	GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS	Jan 06, 2005	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K043244	FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR	Dec 20, 2004	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K041005	GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS	Oct 07, 2004	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K041726	HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX	Jul 23, 2004	Substantially Equivalent	ASAHI MEDICAL CO., LTD.
K041424	NXSTAGE SYSTEM ONE	Jul 02, 2004	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K040696	MODIFICATION TO NXSTAGE SYSTEM ONE	May 26, 2004	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K040255	POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE	May 24, 2004	Substantially Equivalent	GAMBRO RENAL PRODUCTS, INC.
K040489	AQUADEX SYSTEM 100, MODEL A1100	Apr 27, 2004	Substantially Equivalent	CHF SOLUTIONS, INC.
K034064	FRESENIUS ULTRAFLO HPX HEMODIALYZER	Jan 30, 2004	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K023874	SYSTEM 100 ULTRAFILTRATION CATHETER	Nov 20, 2003	Substantially Equivalent	CHF SOLUTIONS, INC.
K023509	DBB-05 HEMODIALYSIS DELIVERY SYSTEM	Oct 30, 2003	Substantially Equivalent	DAVITA CLINICAL RESEARCH (TRRI)
K032356	NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS	Oct 28, 2003	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K030050	TORAYSULFONE DIALYZER, BS-L SERIES	Sep 29, 2003	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K032431	PRISMA M60/M100 SETS	Sep 15, 2003	Substantially Equivalent	GAMBRO, INC.
K030099	BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000	Jun 17, 2003	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K031378	FRESENIUS ULTRAFLUX HEMODIALYZER	May 30, 2003	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K030592	GAMBRO POLYFLUX, MODEL 140H, 170H, 210H	May 23, 2003	Substantially Equivalent	GAMBRO RENAL CARE PRODUCTS
K030975	EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210	Apr 25, 2003	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K030974	EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170	Apr 25, 2003	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K024124	SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT	Mar 14, 2003	Substantially Equivalent	CHF SOLUTIONS, INC.
K023664	SYNTRA + DIALYZER, MODEL 200	Feb 21, 2003	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K013562	AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE	Dec 12, 2002	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K014152	NXSTAGE CARTRIDGE EXPRESS	Dec 11, 2002	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K021615	BAXTER ACCURA SYSTEM, MODEL 5M5660	Nov 18, 2002	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K021732	DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT	Nov 04, 2002	Substantially Equivalent	DIDECO S.P.A.
K023224	INFUSION CATHETER EXTENSION SET	Oct 25, 2002	Substantially Equivalent	CHF SOLUTIONS, INC.
K010805	PRISMA SYSTEM	Aug 06, 2002	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K013418	AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY	Jul 09, 2002	Substantially Equivalent	ASAHI MEDICAL CO., LTD
K013733	SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET	Jun 03, 2002	Substantially Equivalent	CHF SOLUTIONS, INC.
K020858	NXSTAGE THERAPY SYSTEM	Apr 17, 2002	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K010131	PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB	Mar 26, 2002	Substantially Equivalent	AKSYS, LTD.
K011269	LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR	Mar 04, 2002	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K011537	DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS	Jan 07, 2002	Substantially Equivalent	DYNAMIC TECHNOLOGY CORP.
K013550	CLIRANS E-SERIES DIALYZER	Nov 20, 2001	Substantially Equivalent	TERUMO MEDICAL CORP.
K011221	PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET	Oct 31, 2001	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K012510	MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM	Oct 19, 2001	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K002512	TORAYSULFONE DIALYZER	Oct 15, 2001	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K010985	GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L	Oct 10, 2001	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K010667	GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R	Jun 04, 2001	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K003023	COBE HC 700 MIDI HEMOCONCENTRATOR	Apr 30, 2001	Substantially Equivalent	HOSPAL INDUSTRIE
K000724	MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300	Mar 22, 2001	Substantially Equivalent	MEDICA S.R.L.
K002210	SYNTRA DIALYZER, MODEL SYNTRA 120, 160	Feb 14, 2001	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K003425	CLIRANS E-SERIES HOLLOW FIBER DIALYZERS	Feb 01, 2001	Substantially Equivalent	TERUMO MEDICAL CORP.
K001283	LIFEMATE HEMOFILTRATION SYSTEM	Jan 17, 2001	Substantially Equivalent	NXSTAGE MEDICAL, INC.
K003498	FRESENIUS OPTIFLUX 200A	Jan 04, 2001	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K994198	HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L	Aug 25, 2000	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K002277	FRESENIUS OPTIFLUX 200NR	Aug 25, 2000	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K001250	APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)	Aug 16, 2000	Substantially Equivalent	ASAHI MEDICAL CO., LTD.
K001156	PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET	Jul 07, 2000	Substantially Equivalent	GAMBRO RENAL PRODUCTS
K001422	PSN HEMODIALYZER, MODELS PSN 170, PSN 210	Jun 02, 2000	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K000028	RENAFLO II HF 2000 HEMOFILTER	Apr 04, 2000	Substantially Equivalent	MINNTECH CORP.
K994267	FRESENIUS 2008K	Mar 16, 2000	Substantially Equivalent	FRESENIUS MEDICAL CARE
K992573	AF-220 HEMODIALYZER	Jan 18, 2000	Substantially Equivalent	ALTHIN MEDICAL AB
K992566	AF-150 HEMODIALYZER	Jan 18, 2000	Substantially Equivalent	ALTHIN MEDICAL AB
K992564	AF-180 HEMODIALYZER	Jan 18, 2000	Substantially Equivalent	ALTHIN MEDICAL AB
K992563	A-22 HEMODIALYZER	Jan 18, 2000	Substantially Equivalent	ALTHIN MEDICAL AB
K990643	PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015	Dec 07, 1999	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K992894	MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576	Nov 24, 1999	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K993064	PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)	Oct 06, 1999	Substantially Equivalent	GAMBRO RENAL CARE PRODUCTS
K982926	FRESENIUS BLOOD VOLUME MONITOR	Sep 03, 1999	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K992275	FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS	Aug 04, 1999	Substantially Equivalent	FRESENIUS USA, INC.
K991520	FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION	Jul 30, 1999	Substantially Equivalent	FRESENIUS MEDICAL CARE NORTH AMERICA
K982413	COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS	Apr 21, 1999	Substantially Equivalent	GAMBRO HEALTHCARE
K982134	DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851	Apr 14, 1999	Substantially Equivalent	DYNAMIC TECHNOLOGY CORP.
K982414	GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS	Mar 26, 1999	Substantially Equivalent	GAMBRO HEALTHCARE
K980386	HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)	Feb 24, 1999	Substantially Equivalent	GAMBRO HEALTHCARE
K983085	HEMOCOR HPH 700 HEMOCONCENTRATOR	Nov 13, 1998	Substantially Equivalent	MINNTECH CORP.
K973322	DIAPACT CRRT	Nov 10, 1998	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K982760	COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET	Nov 04, 1998	Substantially Equivalent	GAMBRO HEALTHCARE
K981681	PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)	Aug 11, 1998	Substantially Equivalent	GAMBRO HEALTHCARE
K974652	BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER	Jul 10, 1998	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K963440	DIALOG DIALYSIS MACHINE	Jun 26, 1998	Substantially Equivalent	B. BRAUN MEDICAL AG
K980656	PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236	May 19, 1998	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K974584	FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS	May 14, 1998	Substantially Equivalent	FRESENIUS USA, INC.
K980859	HEMOCOR HPH MINI HEMOCONCENTRATOR	May 12, 1998	Substantially Equivalent	MINNTECH CORP.
K973516	CAPIOX HEMOCONCENTRATOR	Jan 30, 1998	Substantially Equivalent	TERUMO MEDICAL CORP.
K970253	COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET	Sep 26, 1997	Substantially Equivalent	GAMBRO HEALTHCARE
K970591	BLOOD MONITOR PUMP	Sep 09, 1997	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K971180	BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT	Jul 24, 1997	Substantially Equivalent	C.R. BARD, INC.
K970739	RMI HEMOCONCENTRATOR PREFERENCE PACK	Jul 08, 1997	Substantially Equivalent	RESEARCH MEDICAL, INC.
K961465	2008H ON LINE CLEARANCE MONITOR	Jul 03, 1997	Substantially Equivalent	FRESENIUS USA, INC.
K970446	DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM	Jun 02, 1997	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K964922	DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM	May 21, 1997	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K955592	COBE CENTRYSYSTEM 14 PES HEMODIALYZERS	Apr 30, 1997	Substantially Equivalent	COBE RENAL CARE, INC.
K955487	GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS	Apr 18, 1997	Substantially Equivalent	COBE RENAL CARE, INC.
K963203	BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT	Mar 25, 1997	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K953996	NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS	Mar 19, 1997	Substantially Equivalent	NIKKISO CO. LTD.
K946279	PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)	Feb 10, 1997	Substantially Equivalent	COBE RENAL CARE, INC.
K955384	DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION	Jan 10, 1997	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K962707	MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET	Oct 09, 1996	Substantially Equivalent	MINNTECH CORP.
K962427	COBE CENTRYSYSTEM 700 HG HEMODIALYZER	Sep 20, 1996	Substantially Equivalent	GAMBRO HEALTHCARE
K960474	COBE CENTRYSYSTEM 600 HG HEMODIALYZERS	Aug 14, 1996	Substantially Equivalent	COBE RENAL CARE, INC.
K954987	ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM	Aug 08, 1996	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K951311	GAMBRO HC 14R HEMOCONCENTRATOR	Jan 11, 1996	Substantially Equivalent	COBE RENAL CARE, INC.
K952983	ALTR NOVA 110 HEMODIALYZER	Oct 05, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K952982	ALTREX 110 HEMODIALYZER	Oct 05, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K952978	ALTRA FLUX 110 HEMODIALYZER	Oct 05, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K952342	GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS	Sep 15, 1995	Substantially Equivalent	COBE RENAL CARE, INC.
K945747	GAMBRO LUNDIA 94-600 DIALYZER	Sep 08, 1995	Substantially Equivalent	COBE RENAL CARE, INC.
K951344	RMI HEMOCONCENTRATOR	Aug 15, 1995	Substantially Equivalent	RESEARCH MEDICAL, INC.
K942681	FILTRYZER	Jun 22, 1995	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K945625	ALTRA NOVA(TM) 140 HEMODIALYZER	May 30, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K945621	ALTRA NOVA(TM) 170 HEMODIALYZER	May 30, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K945542	ALTRA FLUX(TM) 170 HEMODIALYZER	May 23, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K945620	ALTRA FLUX(TM) 140 HEMODIALYZER	May 18, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K950522	CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER	Apr 27, 1995	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K933883	GAMBRO FH 66 D HEMOFILTER	Mar 13, 1995	Substantially Equivalent	COBE RENAL CARE, INC.
K945597	ALTRES(R) 170 HEMODIALYZER	Mar 08, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K945596	ALTRES(R) 140 HEMODIALYZER	Mar 08, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K945595	ALTREX(R) 200 HEMODIALYZER	Mar 08, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K926379	ALTRA NOVA 200 HEMODAILYZER	Feb 13, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K926373	ALTRA FLUX 200 HEMODIALYZER	Feb 13, 1995	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K933818	GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER	Jan 25, 1995	Substantially Equivalent	C.G.H. MEDICAL, INC.
K926568	BAXTER CT DIALYZER	Sep 30, 1994	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K920757	FILTRAL HEMODIALYZERS	Aug 05, 1994	Substantially Equivalent	C.G.H. MEDICAL, INC.
K923727	PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000	Jul 29, 1994	Substantially Equivalent	MINNTECH CORP.
K931720	LUNDIA ALPHA 700 HEMODIALYZER	Jul 07, 1994	Substantially Equivalent	C.G.H. MEDICAL, INC.
K924437	HEMOSPAL KIT B22 / MULTIFLOW 60 KIT	Jun 27, 1994	Substantially Equivalent	C.G.H. MEDICAL, INC.
K923312	HIGH PERMEABILITY DIALYER	Feb 18, 1994	Substantially Equivalent	MINNTECH CORP.
K923139	HEMOCOR HP HEMOCONCENTRATOR SERIES	Feb 18, 1994	Substantially Equivalent	MINNTECH CORP.
K921134	FRESENIUS POLYSULFONE DIALYZERS	Dec 02, 1993	Substantially Equivalent	FRESENIUS USA, INC.
K914020	MODIFIED ASAHI PAN-SERIES HEMOFILTERS	Mar 20, 1992	Substantially Equivalent	ASAHI MEDICAL CO., LTD.
K914363	PERITONEAL DIALYSIS CYCLER SET	Mar 16, 1992	Substantially Equivalent	NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
K913950	DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY	Nov 01, 1991	Substantially Equivalent	ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
K911603	HEMOSPAL KIT B22	Aug 07, 1991	Substantially Equivalent	C.G.H. MEDICAL, INC.
K911094	INPERSOL CAPD BIOCAP ADMINISTRATION SET	Apr 16, 1991	Substantially Equivalent	ABBOTT LABORATORIES
K910236	RENAFLO HDF 1350 HEMODIAFILTER	Apr 09, 1991	Substantially Equivalent	MINNTECH CORP.
K903641	QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q	Nov 09, 1990	Substantially Equivalent	BENTLEY LABORATORIES, INC.
K902837	AMICON DIAFILTER 30 HEMOCONCENTRATOR	Nov 01, 1990	Substantially Equivalent	AMICON, INC.
K900018	HOLLOW FIBER DIALYZER, BIO CARE PS 130	Jul 27, 1990	Substantially Equivalent	NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
K900918	GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER	Jul 16, 1990	Substantially Equivalent	GAMBRO, INC.
K901286	AMICON HEMOCONCENTRATOR SET	May 18, 1990	Substantially Equivalent	AMICON, INC.
K895405	AMICON MINIFILTER PLUS HEMOFILTER	Jan 11, 1990	Substantially Equivalent	AMICON, INC.
K895759	HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H	Nov 08, 1989	Substantially Equivalent	NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
K893742	FILTRAL TM 20 HEMODIALYZER/FILTER	Jul 24, 1989	Substantially Equivalent	HOSPAL MEDICAL CORP.
K892262	FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M	Apr 25, 1989	Substantially Equivalent	FRESENIUS USA, INC.
K883407	TORAY FILTRYZER BK SERIES	Feb 27, 1989	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K890315	CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G	Feb 08, 1989	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K884365	MULTIFLOW(TM) 60 KIT	Dec 08, 1988	Substantially Equivalent	HOSPAL MEDICAL CORP.
K884353	ULTRX(TM) 850 ARTIFICIAL KIDNEY	Dec 08, 1988	Substantially Equivalent	CD MEDICAL, INC.
K884326	FILTRAL TM 8 HEMODIALYZER	Dec 05, 1988	Substantially Equivalent	HOSPAL MEDICAL CORP.
K883307	CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT	Oct 12, 1988	Substantially Equivalent	HOSPAL MEDICAL CORP.
K883195	FRESENIUS F8 DIALYZER	Sep 13, 1988	Substantially Equivalent	FRESENIUS USA, INC.
K872767	FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER	Dec 29, 1987	Substantially Equivalent	HOSPAL MEDICAL CORP.
K873887	MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.	Dec 09, 1987	Substantially Equivalent	W.R. GRACE & CO.-CONN.
K872456	HEMOCOR PLUS HEMOCONCENTRATOR	Sep 15, 1987	Substantially Equivalent	MINNTECH CORP.
K871108	GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER	May 15, 1987	Substantially Equivalent	GAMBRO, INC.
K870724	FRESENIUS HEMOFLOW F60 AND F80	Apr 01, 1987	Substantially Equivalent	SERATRONICS, INC.
K864587	FRESENIUS ULTRAFLUX AV400, AV600	Mar 03, 1987	Substantially Equivalent	SERATRONICS, INC.
K863961	HOSPAL BIOSPAL 1800S	Dec 17, 1986	Substantially Equivalent	HOSPAL MEDICAL CORP.
K864169	FRESENIUS HEMOFLOW F50 & F70	Nov 06, 1986	Substantially Equivalent	SERATRONICS, INC.
K863823	AMICON DIAFILTER HEMOFILTER	Nov 06, 1986	Substantially Equivalent	AMICON, INC.
K861776	HIGH EFFICIENCY HEMODIALYSIS SYSTEM	Jun 19, 1986	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K861106	FRESENIUS HEMOFLOW F80 DIALYZER	Apr 07, 1986	Substantially Equivalent	SERATRONICS, INC.
K860938	GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS	Apr 07, 1986	Substantially Equivalent	GAMBRO, INC.
K855251	MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS	Feb 04, 1986	Substantially Equivalent	ADVOCACY INTERNATIONAL, LTD.
K854586	HOLLOW FIBER DIALYZER	Dec 13, 1985	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K854309	GAMBRO BLOOD CONCENTRATOR SETS 16,60,200	Dec 13, 1985	Substantially Equivalent	GAMBRO, INC.
K854011	RENALFO HEMOFILTER CAVHD	Nov 05, 1985	Substantially Equivalent	RENAL SYSTEMS, INC.
K853510	MINIFILTER HEMOFILTER	Sep 12, 1985	Substantially Equivalent	AMICON, INC.
K852885	FILTRAL HEMODIALYZER	Sep 06, 1985	Substantially Equivalent	HOSPAL MEDICAL CORP.
K853333	DIMENSION TOTAL HIP PROSTHESIS	Sep 03, 1985	Substantially Equivalent	KIRSCHNER MEDICAL CORP.
K850979	HEMOCONCENTRATOR KIT	Jul 29, 1985	Substantially Equivalent	OMNIS SURGICAL, INC.
K852251	FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40	Jul 25, 1985	Substantially Equivalent	SERATRONICS, INC.
K844790	RENAFLO HEMOCONCENTRATOR	May 23, 1985	Substantially Equivalent	RENAL SYSTEMS, INC.
K850866	TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L	Apr 03, 1985	Substantially Equivalent	ERIKA, INC.
K844663	ASAHI NEW PAN-SERIES HEMOFILTERS	Jan 18, 1985	Substantially Equivalent	ASAHI MEDICAL CO., LTD.
K843014	FRESENIUS HAEMODIALYSIS A2008	Oct 18, 1984	Substantially Equivalent	SERATRONICS, INC.
K841585	AMER. BENTLEY CONTINU-BLOOD PROCESSOR-	Oct 18, 1984	Substantially Equivalent	AMERICAN BENTLEY
K841152	HOSPAL BIOSPAL SCU/CAVH KIT	Jul 06, 1984	Substantially Equivalent	HOSPAL MEDICAL CORP.
K840680	CENTRY 2000 DIALYSIS CONTROL UNIT	Apr 20, 1984	Substantially Equivalent	COBE LABORATORIES, INC.
K840543	BLOOD CONCENTRATOR 140	Mar 23, 1984	Substantially Equivalent	GAMBRO, INC.
K840449	AMICON DIAFILTER 40. HEMOFILTER	Mar 23, 1984	Substantially Equivalent	MEDICAL DEVICE CONSULTANTS, INC.
K834589	BIOSPAL (R) 1800S	Feb 04, 1984	Substantially Equivalent	HOSPAL MEDICAL CORP.
K831784	HEMOFILTRATION SYSTEM	Feb 04, 1984	Substantially Equivalent	GAMBRO, INC.
K832547	ULTRAFILTRATION CONTROLLER	Jan 03, 1984	Substantially Equivalent	EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K832659	BIOSPAL 1200S	Sep 20, 1983	Substantially Equivalent	HOSPAL MEDICAL CORP.
K832645	BIOSPAL 3000 S	Sep 20, 1983	Substantially Equivalent	HOSPAL MEDICAL CORP.
K830595	MONITRAL	Apr 28, 1983	Substantially Equivalent	HOSPAL MEDICAL CORP.
K830487	HEMO-PROCESSING SYSTEM	Apr 28, 1983	Substantially Equivalent	SARTORIUS FILTERS, INC.
K830596	ULTRAFILTRATION MONITOR UFM-10-2	Apr 27, 1983	Substantially Equivalent	GAMBRO, INC.
K830648	H1207	Mar 29, 1983	Substantially Equivalent	HOSPAL MEDICAL CORP.
K830647	H1210	Mar 29, 1983	Substantially Equivalent	HOSPAL MEDICAL CORP.
K830284	FH 101, FH 202 & FH 303 FIBER HEMOFILTER	Mar 02, 1983	Substantially Equivalent	GAMBRO, INC.
K823881	ARTERIOVENOUS BLOOD TUBING SET FOR	Jan 17, 1983	Substantially Equivalent	AMICON, INC.
K823338	COBE HEMOCONCENTRATOR 1.3	Jan 07, 1983	Substantially Equivalent	COBE LABORATORIES, INC.
K823589	H 12 07	Dec 22, 1982	Substantially Equivalent	HOSPAL MEDICAL CORP.
K823288	AMICON DIAFILTERS 20 & 30 HEMOFILTERS	Dec 16, 1982	Substantially Equivalent	AMICON, INC.
K813591	HEMOFILTERS	Mar 31, 1982	Substantially Equivalent	AMICON, INC.
K820243	CONTINUOUS BLOOD PROCESSOR CBP-6000 &	Mar 25, 1982	Substantially Equivalent	BENTLEY LABORATORIES, INC.
K812575	MODEL H12-10	Oct 19, 1981	Substantially Equivalent	HOSPAL MEDICAL CORP.
K811830	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	Sep 21, 1981	Substantially Equivalent	CORDIS CORP.
K811944	GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER	Aug 31, 1981	Substantially Equivalent	GAMBRO, INC.
K801480	GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ	Aug 27, 1980	Substantially Equivalent	GAMBRO, INC.
K801479	GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-	Aug 27, 1980	Substantially Equivalent	GAMBRO, INC.
K801731	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	Aug 13, 1980	Substantially Equivalent	CORDIS CORP.
K800536	MODEL H 607-.67M2 30 MICRON RP AN69 MEM	Aug 07, 1980	Substantially Equivalent	HOSPAL MEDICAL CORP.
K801303	MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST	Jul 28, 1980	Substantially Equivalent	WESTERN LABORATORIES CORP.
K790827	RP-610 PARALLEL PLATE DIALYZER	Sep 04, 1979	Substantially Equivalent	HOSPAL MEDICAL CORP.
K781464	HEMODIALYZER, MODEL RP610, RP AN 69	Dec 20, 1978	Substantially Equivalent	HOSPAL MEDICAL CORP.
K780527	CORTRAL I	Dec 20, 1978	Substantially Equivalent	HOSPAL MEDICAL CORP.

FEI Numbers

This FDA classification entry is associated with 81 FEI numbers. Click on an entry to view related FDA registrations.

1000191953: 9 registrations

1000203464: 30 registrations

1000286794: 19 registrations

1000312731: 6 registrations

1000359047: 7 registrations

1527681: 6 registrations

1713747: 4 registrations

1721676: 747 registrations

2150060: 31 registrations

2183744: 663 registrations

2828: 68 registrations

3000203066: 50 registrations

3000247873: 52 registrations

3001236277: 474 registrations

3001451489: 59 registrations

3001744144: 4 registrations

3002654698: 18 registrations

3002806443: 38 registrations

3002806469: 63 registrations

3002806960: 1 registration

3002807005: 5 registrations

3002807035: 8 registrations

3002807111: 309 registrations

3002807113: 241 registrations

3002807196: 5 registrations

3002807204: 6 registrations

3002807408: 15 registrations

3002807710: 11 registrations

3002807721: 4 registrations

3002807744: 29 registrations

3002808327: 59 registrations

3002879653: 9 registrations

3002924544: 78 registrations

3002974635: 25 registrations

3003058448: 327 registrations

3003337893: 6 registrations

3003464075: 25 registrations

3003504604: 13 registrations

3003589956: 25 registrations

3004111573: 356 registrations

3004176176: 10 registrations

3004201412: 3 registrations

3004530184: 33 registrations

3005426550: 105 registrations

3005695808: 14 registrations

3006174295: 40 registrations

3007137787: 4 registrations

3008307705: 125 registrations

3010325717: 5 registrations

3010355846: 8 registrations

3010377171: 4 registrations

3011554160: 99 registrations

3011659185: 17 registrations

3012102437: 51 registrations

3012149633: 1 registration

3012394756: 5 registrations

3012494290: 762 registrations

3013188547: 138 registrations

3013536188: 4 registrations

3013557562: 654 registrations

3013764800: 172 registrations

3014272786: 2 registrations

3014279513: 106 registrations

3014300273: 1 registration

3014479313: 106 registrations

3014579161: 117 registrations

3015335038: 32 registrations

3015349756: 1 registration

3015472042: 2 registrations

3016096143: 11 registrations

3016250252: 1 registration

3016678045: 154 registrations

3017491691: 11 registrations

3017552925: 6 registrations

3020689844: 3 registrations

3027592507: 2 registrations

3031565407: 4 registrations

3032828299: 22 registrations

3035708507: 11 registrations

3038138522: 7 registrations

6898: 6 registrations

Registration Numbers

This FDA classification entry is associated with 81 registration numbers. Click on an entry to view related FDA registrations.

1000286794: 19 registrations

1000312731: 6 registrations

1000359047: 7 registrations

1225714: 59 registrations

1649518: 474 registrations

1713747: 4 registrations

1721676: 747 registrations

2032098: 327 registrations

2133810: 50 registrations

2150060: 31 registrations

2183744: 663 registrations

3000247873: 52 registrations

3001744144: 4 registrations

3002807408: 15 registrations

3002879653: 9 registrations

3003337893: 6 registrations

3003464075: 25 registrations

3003504604: 13 registrations

3003589956: 25 registrations

3004111573: 356 registrations

3004176176: 10 registrations

3004201412: 3 registrations

3004530184: 33 registrations

3005162618: 6 registrations

3005695808: 14 registrations

3005941719: 309 registrations

3006174295: 40 registrations

3007137787: 4 registrations

3008102042: 78 registrations

3008307705: 125 registrations

3010325717: 5 registrations

3010355846: 8 registrations

3010377171: 4 registrations

3011554160: 99 registrations

3011659185: 17 registrations

3012102437: 51 registrations

3012149633: 1 registration

3012494290: 762 registrations

3013188547: 138 registrations

3013536188: 4 registrations

3013557562: 654 registrations

3013764800: 172 registrations

3014272786: 2 registrations

3014279513: 106 registrations

3014300273: 1 registration

3014479313: 106 registrations

3014579161: 117 registrations

3015335038: 32 registrations

3015349756: 1 registration

3015472042: 2 registrations

3016096143: 11 registrations

3016250252: 1 registration

3016678045: 154 registrations

3017491691: 11 registrations

3017552925: 6 registrations

3020689844: 3 registrations

3027592507: 2 registrations

3031565407: 4 registrations

3032828299: 22 registrations

3035708507: 11 registrations

3038138522: 7 registrations

8010026: 68 registrations

8010182: 6 registrations

8030639: 6 registrations

8030665: 29 registrations

8031561: 4 registrations

8041145: 25 registrations

9610270: 5 registrations

9610825: 63 registrations

9610987: 11 registrations

9611369: 8 registrations

9611823: 5 registrations

9611824: 1 registration

9612052: 38 registrations

9615942: 9 registrations

9616074: 18 registrations

9616240: 5 registrations

9680579: 30 registrations

9680841: 105 registrations

9681465: 241 registrations

9681834: 59 registrations