Dialyzer, Capillary, Hollow Fiber
FDA product code FJI · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
131510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Gambro, Inc. 10
- Baxter Healthcare Corp 9
- National Medical Care, Medical Products Div., Inc. 9
- Erika, Inc. 8
- Cordis Corp. 8
- Organon Teknika Corp. 7
- Cobe Laboratories, Inc. 6
- Althin Medical AB an Affiliate of Baxter Intl 6
- Terumo Medical Corp. 6
- Travenol Laboratories, S.A. 5
- Terumo America, Inc. 5
- Hospal Medical Corp. 4
- Asahi Medical Co., Ltd. 4
- Toray Industries (America), Inc. 4
- Dayspring Medical, Inc. 3
- Extracorporeal Medical Specialities, Inc. 3
- Renal Systems, Inc. 3
- Cobe Renal Care, Inc. 2
- Seratronics, Inc. 2
- Bentley Laboratories, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
| K990159 | Dynamic Hollow Fiber Dialyzer Dh-Series, Model Ah 90111FJI · Traditional | Dynamic Technology Corp. | 04/19/1999SE |
| K982337 | Cuprophan and Hemophan Hollow Fiber DialyzerFJI · Traditional | Haidylena Medical Egypt | 12/29/1998SE |
| K981253 | Ultracon UltrafiltratorFJI · Traditional | Interpore Intl. | 12/11/1998SE |
| K980658 | PSN Dialyzer, Model PSN 130/R5M4233, Model PSN-150/R5M4234FJI · Traditional | Baxter Healthcare Corp | 05/19/1998SE |
| K971710 | Ultracon UltrafiltratorFJI · Traditional | Quantic Biomedical, Inc. | 02/27/1998SE |
| K973291 | Dynamic Hollow Fiber Dialyzer Dc-SeriesFJI · Traditional | Dynamic Technology Corp. | 12/19/1997SE |
| K970708 | Clirans T-Series Hollow Fiber DialyzersFJI · Traditional | Terumo Medical Corp. | 12/19/1997SE |
| K963933 | PSN-120 Hollow Fiber Dialyzer and PSN-140 Hollow Fiber DialyzerFJI · Traditional | Baxter Healthcare Corp | 11/24/1997SE |
| K962309 | Alternate Encapsulating Resin System for Mca HemodialyzersFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 12/27/1996SE |
| K961039 | Bllod Port Cap, Dialysate Port Cap, Vented Dialysate Port Cap with Red Pliable VinylFJI · Traditional | Dayspring Medical, Inc. | 09/12/1996SE |
| K961040 | Blood Port Cap, Dialysate Port Cap, Red Hard PlasticFJI · Traditional | Dayspring Medical, Inc. | 06/11/1996SE |
| K961026 | Blood Port Cap, Luer-Lock Fitting, Dayspring Medical Part No. BPC252LLFJI · Traditional | Dayspring Medical, Inc. | 06/10/1996SE |
| K944436 | Cobe Centrysystem CS 200 DialyzerFJI · Traditional | Cobe Renal Care, Inc. | 01/29/1996SE |
| K952343 | Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber DialyzerFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 12/22/1995SE |
| K950602 | Port Caps (Protective Closures Foe Reprocessed HemodialyzersFJI · Traditional | Reprocessing Products Corp | 11/30/1995SE |
| K945746 | Gambro Lundia 94-500 DialyzerFJI · Traditional | Cobe Renal Care, Inc. | 09/08/1995SE |
| K945622 | Mca(Tm) 180 HemodialyzerFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 05/25/1995SE |
| K935471 | Filtryzer(Tm)FJI · Traditional | Toray Industries (America), Inc. | 05/19/1995SE |
| K945631 | 155 Sce(Tm) HemodialyzerFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 05/18/1995SE |
| K945624 | Mca(Tm) 160 HemodialyzerFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 05/18/1995SE |
| K945623 | Mca(Tm) 130 HemodialyzerFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 05/18/1995SE |
| K941708 | Cobe Centrysystem CS500 DialyzerFJI · Traditional | C.G.H. Medical, Inc. | 05/12/1995SE |
| K940910 | FiltryzerFJI · Traditional | Toray Industries (America), Inc. | 05/04/1995SE |
| K950454 | Cahp High Performance Cellulose Diacetate Hollow Fiber DialyzerFJI · Traditional | Baxter Healthcare Corp | 04/27/1995SE |
| K930503 | Clirans Wet Pack Hollow Fiber DialyzerFJI · Traditional | Terumo Medical Corp. | 03/06/1995SE |
| K926372 | Mca 200 HempdialyzerFJI · Traditional | Althin Medical AB an Affiliate of Baxter Intl | 02/13/1995SE |
| K926567 | Baxter Ca DialyzerFJI · Traditional | Baxter Healthcare Corp | 01/11/1995SE |
| K926005 | Fresenius Hemoflow, Various ModelsFJI · Traditional | Fresenius USA, Inc. | 08/23/1994SE |
| K914790 | Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 03/05/1993SE |
| K905779 | AldetectFJI · Traditional | Pochemco, Inc. | 05/23/1991SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | Cobe Laboratories, Inc. | 12/12/1990SE |
| K905228 | Model CA.150 Cellulose Acetate Hollow Fiber DialyzFJI · Traditional | Baxter Healthcare Corp | 12/10/1990SE |
| K903567 | Bio* Nephross Andante, Moderato, Allegio H.F.FJI · Traditional | Organon Teknika Corp. | 09/24/1990SE |
| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | Gambro, Inc. | 07/27/1990SE |
| K893677 | Hollow Fiber Dialyzer Focus 70HFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 07/24/1989SE |
| K891477 | Clirans Hollow Fiber Hemodialyzer (Wet)FJI · Traditional | Terumo Medical Corp. | 06/09/1989SE |
| K892375 | Modified Am-Series DialyzersFJI · Traditional | Asahi Medical Co., Ltd. | 05/18/1989SE |
| K892374 | New Am-Series DialyzersFJI · Traditional | Asahi Medical Co., Ltd. | 05/18/1989SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | Gambro, Inc. | 05/11/1989SE |
| K884339 | Toray Filtryzer DialyzersFJI · Traditional | Toray Industries (America), Inc. | 03/17/1989SE |
| K890111 | Gambro Alwall Gfe 8 & 9 Hollow Fiber DialyzerFJI · Traditional | Gambro, Inc. | 02/08/1989SE |
| K883748 | Renak-E & Renek-A Series Hollow Fiber DialyzersFJI · Traditional | Kawasumi Laboratories Co., Ltd. | 01/31/1989SE |
| K883644 | Capillary Flow Dialyzers Models Ht. 130 & 170FJI · Traditional | Baxter Healthcare Corp | 10/21/1988SE |
| K883534 | Capillary Flow Dialyzers Models HT.80 & HT.100FJI · Traditional | Baxter Healthcare Corp | 10/21/1988SE |
| K883589 | Gambro Alwall Gfe 12 & 18 Hollow Fiber DialyzerFJI · Traditional | Gambro, Inc. | 09/29/1988SE |
| K881811 | Cobe Centrysystem Hollow Fiber DialyzersFJI · Traditional | Cobe Laboratories, Inc. | 09/15/1988SE |
| K882158 | Modified Toray Filtryzer DialyzersFJI · Traditional | Toray Industries (America), Inc. | 08/12/1988SE |
| K882680 | Alternate Blood Port Design for Addit. Memb. of CaFJI · Traditional | Baxter Healthcare Corp | 07/22/1988SE |
| K882339 | Bio*Nephross I.Q. AndanteFJI · Traditional | Organon Teknika Corp. | 06/28/1988SE |
| K882215 | Nephross I.Q. ModeratoFJI · Traditional | Organon Teknika Corp. | 06/28/1988SE |
| K882213 | Nephross I.Q. AllegoFJI · Traditional | Organon Teknika Corp. | 06/28/1988SE |
| K880084 | GF 120M, 120H, 180M & 180H Hollow Fiber DialyzersFJI · Traditional | Gambro, Inc. | 02/19/1988SE |
| K874872 | Fresenius Hemoflow F3, F4, F5, F7FJI · Traditional | Seratronics, Inc. | 02/19/1988SE |
| K874728 | Capillary Flow DialyzersFJI · Traditional | Baxter Healthcare Corp | 01/29/1988SE |
| K874549 | Nephross I.Q. AndanteFJI · Traditional | Organon Teknika Corp. | 01/29/1988SE |
| K880083 | Gambro Alwall Gfe 11 & 15 Hollow Fiber DialyzersFJI · Traditional | Gambro, Inc. | 01/27/1988SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | Travenol Laboratories, S.A. | 06/12/1987SE |
| K871236 | Hollow Fiber Dialyzer Focus 70,90,120,90H,120HFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 05/29/1987SE |
| K870725 | Fresenius Hemoflow F6 and F8FJI · Traditional | Seratronics, Inc. | 05/01/1987SE |
| K870169 | Capillary Flow DialyzersFJI · Traditional | Travenol Laboratories, S.A. | 04/06/1987SE |
| K864831 | Cobe Centrysystem 145E,160E,175E,190E DialyzersFJI · Traditional | Cobe Laboratories, Inc. | 03/27/1987SE |
| K863044 | Capillary Flow Hollow Fiber DialyzersFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 03/27/1987SE |
| K863592 | Disscap 80E, 110E, 140E, 160EFJI · Traditional | Hospal Medical Corp. | 09/25/1986SE |
| K862693 | Toray Filtryzer Dialyzer, B1-2.0.FJI · Traditional | National Medical Care, Medical Products Div., Inc. | 07/22/1986SE |
| K861916 | Advanced Performance Hollow Fiber DialyzerFJI · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K861537 | Advanced Perform Hollow Fiber Dialyzer, 019752-5FJI · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K861536 | Advanced Perform Hollow Fiber Dialyzer, 01-9751-7FJI · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | Advocacy International, Ltd. | 01/21/1986SE |
| K854280 | Clirans Taf Hollow Fiber DialyzerFJI · Traditional | Terumo Medical Corp. | 12/13/1985SE |
| K854575 | Modified Am-Series DialyzersFJI · Traditional | Asahi Medical Co., Ltd. | 12/02/1985SE |
| K853591 | Dialyzer, Capillary, Hollow FiberFJI · Traditional | Organon Teknika Corp. | 09/11/1985SE |
| K851380 | Disscap 110 DialyzerFJI · Traditional | Hospal Medical Corp. | 04/25/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | Erika, Inc. | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | Erika, Inc. | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | Erika, Inc. | 03/07/1985SE |
| K820524 | Clirans Hollow Fiber DialyzersFJI · Traditional | Terumo Medical Corp. | 07/08/1982SE |
| K821587 | Erika HPF 50 DialyzerFJI · Traditional | Erika, Inc. | 06/25/1982SE |
| K820743 | Hollow Fiber DialyzersFJI · Traditional | Terumo Medical Corp. | 06/23/1982SE |
| K821690 | Erika HPF 100,200,300 DialyzerFJI · Traditional | Erika, Inc. | 06/22/1982SE |
| K820304 | Gambro GF-80-M, GF-80-H HemodialyzerFJI · Traditional | Gambro, Inc. | 03/02/1982SE |
| K812353 | Kf-E Series of Hollow Fiber DialyzersFJI · Traditional | Medisystems Corp. | 09/16/1981SE |
| K802894 | Cordis Dow C-Dak 1.8MRC Artific-KidneyFJI · Traditional | Cordis Corp. | 02/19/1981SE |
| K802893 | Cordis Dow C-Dak 1.3MRC Artif. KidneyFJI · Traditional | Cordis Corp. | 02/13/1981SE |
| K802613 | C-Pak Model 12 Artificial KidneyFJI · Traditional | Cordis Corp. | 01/07/1981SE |
| K802441 | Clirans TH10 Hollow Fiber DialyzerFJI · Traditional | Terumo America, Inc. | 12/18/1980SE |
| K802122 | Clirans TH13 Hollow Fiber DialyzerFJI · Traditional | Terumo America, Inc. | 12/18/1980SE |
| K802114 | Nephross DialyzerFJI · Traditional | Organon Teknika Corp. | 12/18/1980SE |
| K802092 | HF-100 DialyzerFJI · Traditional | Bio-Med Corp. | 12/18/1980SE |
| K802466 | Disscap Hollow Fiber DialyzerFJI · Traditional | Hospal Medical Corp. | 11/12/1980SE |
| K801559 | Hollo Fiber DialyzerFJI · Traditional | Renal Devices, Inc. | 10/31/1980SE |
| K801827 | Renaflo Hollow Fiber Dialyzer #100.1FJI · Traditional | Renal Systems, Inc. | 09/26/1980SE |
| K801826 | Renaflo Hollow Fiber Dialyzers #Mp 140FJI · Traditional | Renal Systems, Inc. | 09/26/1980SE |
| K801825 | Renaflo Hollow Fiber Dialyzers S.M.A.D.FJI · Traditional | Renal Systems, Inc. | 09/26/1980SE |
| K801194 | Clirans TE07 Hollow Fiber DialyzerFJI · Traditional | Terumo America, Inc. | 08/12/1980SE |
| K801192 | Clirans TE10 Hollow Fiber DialyzerFJI · Traditional | Terumo America, Inc. | 08/12/1980SE |
| K801178 | Cobe HF80, Cat. #18-580FJI · Traditional | Cobe Laboratories, Inc. | 07/28/1980SE |
| K801370 | GF-120-L DialyzerFJI · Traditional | Gambro, Inc. | 07/21/1980SE |
| K801344 | Extracorporeals' Alternate MembraneFJI · Traditional | Extracorporeal Medical Specialities, Inc. | 07/21/1980SE |
| K801045 | GF120H DialyzerFJI · Traditional | Gambro, Inc. | 06/30/1980SE |
| K800704 | C-Dak TM 2800 Artificial KidneyFJI · Traditional | Cordis Corp. | 05/08/1980SE |
| K800336 | Gambro Lundia FiberFJI · Traditional | Gambro, Inc. | 05/02/1980SE |
| K800549 | Model Triex-L Hollow Fiber DialyzerFJI · Traditional | Extracorporeal Medical Specialities, Inc. | 04/10/1980SE |
| K800270 | TRIEX-2 Hollow Fiber DialyzerFJI · Traditional | Extracorporeal Medical Specialities, Inc. | 02/26/1980SE |
| K800221 | CF/211 Capillary Flow Dialyzer, #5M1784FJI · Traditional | Travenol Laboratories, S.A. | 02/26/1980SE |
| K792419 | C-Dak 2100 Artificial KidneyFJI · Traditional | Cordis Corp. | 01/16/1980SE |
| K791322 | Erika HPF 300FJI · Traditional | Erika, Inc. | 09/24/1979SE |
| K791321 | Erika HPF 200FJI · Traditional | Erika, Inc. | 09/24/1979SE |
| K791320 | Erika HPF 100FJI · Traditional | Erika, Inc. | 09/24/1979SE |
| K790696 | RDI-1 Hollow Fiber DialyzerFJI · Traditional | Renal Devices, Inc. | 06/20/1979SE |
| K790308 | Disposable Dialyzers, Sd-Id, SD-2DFJI · Traditional | Bentley Laboratories, Inc. | 05/01/1979SE |
| K790067 | Flow Dialyzer, CF 2300 CapillaryFJI · Traditional | Travenol Laboratories, S.A. | 04/10/1979SE |
| K782151 | Artificial Kidney, C-Dak 0.6DFJI · Traditional | Cordis Corp. | 02/22/1979SE |
| K781142 | DisscapFJI · Traditional | Hospal Medical Corp. | 09/14/1978SE |
| K781058 | C-Dak 4000 Artificial KidneyFJI · Traditional | Cordis Corp. | 08/23/1978SE |
| K772290 | Dialyzer, Capilatory, Hollow FiberFJI · Traditional | Redy Laboratories | 03/15/1978SE |
| K772423 | Spiraflow DialyzersFJI · Traditional | Bentley Laboratories, Inc. | 01/26/1978SE |
| K771694 | Clirans TH 15 Hollow Fiber DialyzerFJI · Traditional | Terumo America, Inc. | 09/15/1977SE |
| K770867 | Dialyzer, Fiber, HollowFJI · Traditional | Cobe Laboratories, Inc. | 06/14/1977SE |
| K770734 | Dialyzer, Fiber, HollowFJI · Traditional | Travenol Laboratories, S.A. | 05/10/1977SE |
| K761007 | Artificial Kidney, C-Dak Cordis DowFJI · Traditional | Cordis Corp. | 01/12/1977SE |
| K760252 | Dialyzer, HF 130 Hollow FiberFJI · Traditional | Cobe Laboratories, Inc. | 10/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0041-2026 Class II | Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS…To provide further information to the user to ensure proper use of the medical device. the caps had been… | Fresenius Medical Care Holdings, Inc. | 08/29/2025Open, Classified |
| Z-1324-2016 Class II | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic…Dialyzer header leak due to possible improper torque | Fresenius Medical Care Renal Therapies… | 02/26/2016Terminated |
| Z-0175-2007 | Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer…There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple… | Asahi Medical Co., Ltd | 10/12/2006Terminated |