Product Code: FJI FDA class 2 21 CFR 876.5820

Dialyzer, Capillary, Hollow Fiber

Gastroenterology, Urology

The Capillary Hollow Fiber Dialyzer is a hemodialysis device in which blood flows through thousands of hollow semipermeable fibers arranged in a bundle, while dialysate flows in the opposite direction around the fibers, enabling efficient solute clearance and fluid removal. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJI, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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510(k)s

131

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FJI
Device Class: FDA class 2
Regulation Number: 876.5820
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 131 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K190459	Hemoflow F3 and F4 Dialyzers	Aug 23, 2019	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K122952	NIPRO PUREFLUX-L HEMODIALYZER	Dec 04, 2013	Substantially Equivalent	Nipro Medical Corporation
K043342	POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR	May 27, 2005	Substantially Equivalent	Gambro Renal Products
K010366	DISPOSABLE STORAGE CAP	Nov 28, 2001	Substantially Equivalent	Molded Products, Inc.
K011148	ULTRACONCENTRATOR SYSTEM	Jun 13, 2001	Substantially Equivalent	Interpore Cross Intl.
K002761	FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS	Dec 04, 2000	Substantially Equivalent	Fresenius Medical Care North America
K991908	IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS	Apr 17, 2000	Substantially Equivalent	Idemsa
K992594	A-15 HEMODIALYZER	Sep 24, 1999	Substantially Equivalent	Althin Medical AB
K992565	A-18 HEMODIALYZER	Sep 23, 1999	Substantially Equivalent	Althin Medical AB
K991512	ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X	Jul 29, 1999	Substantially Equivalent	Asahi Medical Co., Ltd.
K990159	DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111	Apr 19, 1999	Substantially Equivalent	Dynamic Technology Corp.
K982337	CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER	Dec 29, 1998	Substantially Equivalent	Haidylena Medical Egypt
K981253	ULTRACON ULTRAFILTRATOR	Dec 11, 1998	Substantially Equivalent	Interpore Intl.
K980658	PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234	May 19, 1998	Substantially Equivalent	Baxter Healthcare Corp
K971710	ULTRACON ULTRAFILTRATOR	Feb 27, 1998	Substantially Equivalent	Quantic Biomedical, Inc.
K973291	DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES	Dec 19, 1997	Substantially Equivalent	Dynamic Technology Corp.
K970708	CLIRANS T-SERIES HOLLOW FIBER DIALYZERS	Dec 19, 1997	Substantially Equivalent	Terumo Medical Corp.
K963933	PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER	Nov 24, 1997	Substantially Equivalent	Baxter Healthcare Corp
K962309	ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS	Dec 27, 1996	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K961039	BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL	Sep 12, 1996	Substantially Equivalent	Dayspring Medical, Inc.
K961040	BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC	Jun 11, 1996	Substantially Equivalent	Dayspring Medical, Inc.
K961026	BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL	Jun 10, 1996	Substantially Equivalent	Dayspring Medical, Inc.
K944436	COBE CENTRYSYSTEM CS 200 DIALYZER	Jan 29, 1996	Substantially Equivalent	Cobe Renal Care, Inc.
K952343	FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER	Dec 22, 1995	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K950602	PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS	Nov 30, 1995	Substantially Equivalent	Reprocessing Products Corp
K945746	GAMBRO LUNDIA 94-500 DIALYZER	Sep 08, 1995	Substantially Equivalent	Cobe Renal Care, Inc.
K945622	MCA(TM) 180 HEMODIALYZER	May 25, 1995	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K935471	FILTRYZER(TM)	May 19, 1995	Substantially Equivalent	Toray Industries (America), Inc.
K945631	155 SCE(TM) HEMODIALYZER	May 18, 1995	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K945624	MCA(TM) 160 HEMODIALYZER	May 18, 1995	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K945623	MCA(TM) 130 HEMODIALYZER	May 18, 1995	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K941708	COBE CENTRYSYSTEM CS500 DIALYZER	May 12, 1995	Substantially Equivalent	C.G.H. Medical, Inc.
K940910	FILTRYZER	May 04, 1995	Substantially Equivalent	Toray Industries (America), Inc.
K950454	CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER	Apr 27, 1995	Substantially Equivalent	Baxter Healthcare Corp
K930503	CLIRANS WET PACK HOLLOW FIBER DIALYZER	Mar 06, 1995	Substantially Equivalent	Terumo Medical Corp.
K926372	MCA 200 HEMPDIALYZER	Feb 13, 1995	Substantially Equivalent	Althin Medical AB an Affiliate of Baxter Intl
K926567	BAXTER CA DIALYZER	Jan 11, 1995	Substantially Equivalent	Baxter Healthcare Corp
K926005	FRESENIUS HEMOFLOW, VARIOUS MODELS	Aug 23, 1994	Substantially Equivalent	Fresenius USA, Inc.
K914790	HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R	Mar 05, 1993	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K905779	ALDETECT	May 23, 1991	Substantially Equivalent	Pochemco, Inc.
K904566	NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER	Dec 12, 1990	Substantially Equivalent	Cobe Laboratories, Inc.
K905228	MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ	Dec 10, 1990	Substantially Equivalent	Baxter Healthcare Corp
K903567	BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.	Sep 24, 1990	Substantially Equivalent	Organon Teknika Corp.
K902481	GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER	Jul 27, 1990	Substantially Equivalent	Gambro, Inc.
K893677	HOLLOW FIBER DIALYZER FOCUS 70H	Jul 24, 1989	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K891477	CLIRANS HOLLOW FIBER HEMODIALYZER (WET)	Jun 09, 1989	Substantially Equivalent	Terumo Medical Corp.
K892375	MODIFIED AM-SERIES DIALYZERS	May 18, 1989	Substantially Equivalent	Asahi Medical Co., Ltd.
K892374	NEW AM-SERIES DIALYZERS	May 18, 1989	Substantially Equivalent	Asahi Medical Co., Ltd.
K892523	GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY	May 11, 1989	Substantially Equivalent	Gambro, Inc.
K884339	TORAY FILTRYZER DIALYZERS	Mar 17, 1989	Substantially Equivalent	Toray Industries (America), Inc.
K890111	GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER	Feb 08, 1989	Substantially Equivalent	Gambro, Inc.
K883748	RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS	Jan 31, 1989	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K883644	CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170	Oct 21, 1988	Substantially Equivalent	Baxter Healthcare Corp
K883534	CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100	Oct 21, 1988	Substantially Equivalent	Baxter Healthcare Corp
K883589	GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER	Sep 29, 1988	Substantially Equivalent	Gambro, Inc.
K881811	COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS	Sep 15, 1988	Substantially Equivalent	Cobe Laboratories, Inc.
K882158	MODIFIED TORAY FILTRYZER DIALYZERS	Aug 12, 1988	Substantially Equivalent	Toray Industries (America), Inc.
K882680	ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA	Jul 22, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882339	BIO*NEPHROSS I.Q. ANDANTE	Jun 28, 1988	Substantially Equivalent	Organon Teknika Corp.
K882215	NEPHROSS I.Q. MODERATO	Jun 28, 1988	Substantially Equivalent	Organon Teknika Corp.
K882213	NEPHROSS I.Q. ALLEGO	Jun 28, 1988	Substantially Equivalent	Organon Teknika Corp.
K880084	GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS	Feb 19, 1988	Substantially Equivalent	Gambro, Inc.
K874872	FRESENIUS HEMOFLOW F3, F4, F5, F7	Feb 19, 1988	Substantially Equivalent	Seratronics, Inc.
K874728	CAPILLARY FLOW DIALYZERS	Jan 29, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874549	NEPHROSS I.Q. ANDANTE	Jan 29, 1988	Substantially Equivalent	Organon Teknika Corp.
K880083	GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS	Jan 27, 1988	Substantially Equivalent	Gambro, Inc.
K871471	CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15	Jun 12, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K871236	HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H	May 29, 1987	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K870725	FRESENIUS HEMOFLOW F6 AND F8	May 01, 1987	Substantially Equivalent	Seratronics, Inc.
K870169	CAPILLARY FLOW DIALYZERS	Apr 06, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K864831	COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS	Mar 27, 1987	Substantially Equivalent	Cobe Laboratories, Inc.
K863044	CAPILLARY FLOW HOLLOW FIBER DIALYZERS	Mar 27, 1987	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K863592	DISSCAP 80E, 110E, 140E, 160E	Sep 25, 1986	Substantially Equivalent	Hospal Medical Corp.
K862693	TORAY FILTRYZER DIALYZER, B1-2.0.	Jul 22, 1986	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K861916	ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER	Jul 10, 1986	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K861537	ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5	Jul 10, 1986	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K861536	ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7	Jul 10, 1986	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K855212	ASAHI AM SERIES DIALYZERS	Jan 21, 1986	Substantially Equivalent	Advocacy International, Ltd.
K854280	CLIRANS TAF HOLLOW FIBER DIALYZER	Dec 13, 1985	Substantially Equivalent	Terumo Medical Corp.
K854575	MODIFIED AM-SERIES DIALYZERS	Dec 02, 1985	Substantially Equivalent	Asahi Medical Co., Ltd.
K853591	DIALYZER, CAPILLARY, HOLLOW FIBER	Sep 11, 1985	Substantially Equivalent	Organon Teknika Corp.
K851380	DISSCAP 110 DIALYZER	Apr 25, 1985	Substantially Equivalent	Hospal Medical Corp.
K850865	TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-	Apr 03, 1985	Substantially Equivalent	Erika, Inc.
K850655	TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2	Mar 07, 1985	Substantially Equivalent	Erika, Inc.
K850654	TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID	Mar 07, 1985	Substantially Equivalent	Erika, Inc.
K820524	CLIRANS HOLLOW FIBER DIALYZERS	Jul 08, 1982	Substantially Equivalent	Terumo Medical Corp.
K821587	ERIKA HPF 50 DIALYZER	Jun 25, 1982	Substantially Equivalent	Erika, Inc.
K820743	HOLLOW FIBER DIALYZERS	Jun 23, 1982	Substantially Equivalent	Terumo Medical Corp.
K821690	ERIKA HPF 100,200,300 DIALYZER	Jun 22, 1982	Substantially Equivalent	Erika, Inc.
K820304	GAMBRO GF-80-M, GF-80-H HEMODIALYZER	Mar 02, 1982	Substantially Equivalent	Gambro, Inc.
K812353	KF-E SERIES OF HOLLOW FIBER DIALYZERS	Sep 16, 1981	Substantially Equivalent	Medisystems Corp.
K802894	CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY	Feb 19, 1981	Substantially Equivalent	Cordis Corp.
K802893	CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY	Feb 13, 1981	Substantially Equivalent	Cordis Corp.
K802613	C-PAK MODEL 12 ARTIFICIAL KIDNEY	Jan 07, 1981	Substantially Equivalent	Cordis Corp.
K802441	CLIRANS TH10 HOLLOW FIBER DIALYZER	Dec 18, 1980	Substantially Equivalent	Terumo America, Inc.
K802122	CLIRANS TH13 HOLLOW FIBER DIALYZER	Dec 18, 1980	Substantially Equivalent	Terumo America, Inc.
K802114	NEPHROSS DIALYZER	Dec 18, 1980	Substantially Equivalent	Organon Teknika Corp.
K802092	HF-100 DIALYZER	Dec 18, 1980	Substantially Equivalent	Bio-Med Corp.
K802466	DISSCAP HOLLOW FIBER DIALYZER	Nov 12, 1980	Substantially Equivalent	Hospal Medical Corp.
K801559	HOLLO FIBER DIALYZER	Oct 31, 1980	Substantially Equivalent	Renal Devices, Inc.
K801827	RENAFLO HOLLOW FIBER DIALYZER #100.1	Sep 26, 1980	Substantially Equivalent	Renal Systems, Inc.
K801826	RENAFLO HOLLOW FIBER DIALYZERS #MP 140	Sep 26, 1980	Substantially Equivalent	Renal Systems, Inc.
K801825	RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.	Sep 26, 1980	Substantially Equivalent	Renal Systems, Inc.
K801194	CLIRANS TE07 HOLLOW FIBER DIALYZER	Aug 12, 1980	Substantially Equivalent	Terumo America, Inc.
K801192	CLIRANS TE10 HOLLOW FIBER DIALYZER	Aug 12, 1980	Substantially Equivalent	Terumo America, Inc.
K801178	COBE HF80, CAT. #18-580	Jul 28, 1980	Substantially Equivalent	Cobe Laboratories, Inc.
K801370	GF-120-L DIALYZER	Jul 21, 1980	Substantially Equivalent	Gambro, Inc.
K801344	EXTRACORPOREALS' ALTERNATE MEMBRANE	Jul 21, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K801045	GF120H DIALYZER	Jun 30, 1980	Substantially Equivalent	Gambro, Inc.
K800704	C-DAK TM 2800 ARTIFICIAL KIDNEY	May 08, 1980	Substantially Equivalent	Cordis Corp.
K800336	GAMBRO LUNDIA FIBER	May 02, 1980	Substantially Equivalent	Gambro, Inc.
K800549	MODEL TRIEX-L HOLLOW FIBER DIALYZER	Apr 10, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K800270	TRIEX-2 HOLLOW FIBER DIALYZER	Feb 26, 1980	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K800221	CF/211 CAPILLARY FLOW DIALYZER, #5M1784	Feb 26, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K792419	C-DAK 2100 ARTIFICIAL KIDNEY	Jan 16, 1980	Substantially Equivalent	Cordis Corp.
K791322	ERIKA HPF 300	Sep 24, 1979	Substantially Equivalent	Erika, Inc.
K791321	ERIKA HPF 200	Sep 24, 1979	Substantially Equivalent	Erika, Inc.
K791320	ERIKA HPF 100	Sep 24, 1979	Substantially Equivalent	Erika, Inc.
K790696	RDI-1 HOLLOW FIBER DIALYZER	Jun 20, 1979	Substantially Equivalent	Renal Devices, Inc.
K790308	DISPOSABLE DIALYZERS, SD-ID, SD-2D	May 01, 1979	Substantially Equivalent	Bentley Laboratories, Inc.
K790067	FLOW DIALYZER, CF 2300 CAPILLARY	Apr 10, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K782151	ARTIFICIAL KIDNEY, C-DAK 0.6D	Feb 22, 1979	Substantially Equivalent	Cordis Corp.
K781142	DISSCAP	Sep 14, 1978	Substantially Equivalent	Hospal Medical Corp.
K781058	C-DAK 4000 ARTIFICIAL KIDNEY	Aug 23, 1978	Substantially Equivalent	Cordis Corp.
K772290	DIALYZER, CAPILATORY, HOLLOW FIBER	Mar 15, 1978	Substantially Equivalent	Redy Laboratories
K772423	SPIRAFLOW DIALYZERS	Jan 26, 1978	Substantially Equivalent	Bentley Laboratories, Inc.
K771694	CLIRANS TH 15 HOLLOW FIBER DIALYZER	Sep 15, 1977	Substantially Equivalent	Terumo America, Inc.
K770867	DIALYZER, FIBER, HOLLOW	Jun 14, 1977	Substantially Equivalent	Cobe Laboratories, Inc.
K770734	DIALYZER, FIBER, HOLLOW	May 10, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K761007	ARTIFICIAL KIDNEY, C-DAK CORDIS DOW	Jan 12, 1977	Substantially Equivalent	Cordis Corp.
K760252	DIALYZER, HF 130 HOLLOW FIBER	Oct 15, 1976	Substantially Equivalent	Cobe Laboratories, Inc.