FJI · Dialyzer, Capillary, Hollow Fiber
Gastroenterology, Urology · 21 CFR 876.5820 · Class 2
Overview
| Product Code | FJI |
|---|---|
| Device Name | Dialyzer, Capillary, Hollow Fiber |
| Regulation | 21 CFR 876.5820 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Life-Sustaining | Yes |
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Classification Rationale
(1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (131)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | Aug 23, 2019 | SESE |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | Nipro Medical Corporation | Dec 4, 2013 | SESE |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | Gambro Renal Products | May 27, 2005 | SESE |
| K010366 | DISPOSABLE STORAGE CAP | Molded Products, Inc. | Nov 28, 2001 | SESE |
| K011148 | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | Jun 13, 2001 | SESE |
| K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | Fresenius Medical Care North America | Dec 4, 2000 | SESE |
| K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | Apr 17, 2000 | SESE |
| K992594 | A-15 HEMODIALYZER | Althin Medical AB | Sep 24, 1999 | SESE |
| K992565 | A-18 HEMODIALYZER | Althin Medical AB | Sep 23, 1999 | SESE |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | Jul 29, 1999 | SESE |
| K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | Apr 19, 1999 | SESE |
| K982337 | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | Haidylena Medical Egypt | Dec 29, 1998 | SESE |
| K981253 | ULTRACON ULTRAFILTRATOR | Interpore Intl. | Dec 11, 1998 | SESE |
| K980658 | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | Baxter Healthcare Corp | May 19, 1998 | SESE |
| K971710 | ULTRACON ULTRAFILTRATOR | Quantic Biomedical, Inc. | Feb 27, 1998 | SESE |
| K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | Dec 19, 1997 | SESE |
| K970708 | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | Dec 19, 1997 | SESE |
| K963933 | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | Nov 24, 1997 | SESE |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | Dec 27, 1996 | SESE |
| K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL | Dayspring Medical, Inc. | Sep 12, 1996 | SESE |
| K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC | Dayspring Medical, Inc. | Jun 11, 1996 | SESE |
| K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL | Dayspring Medical, Inc. | Jun 10, 1996 | SESE |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | Cobe Renal Care, Inc. | Jan 29, 1996 | SESE |
| K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER | National Medical Care, Medical Products Div., Inc. | Dec 22, 1995 | SESE |
| K950602 | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS | Reprocessing Products Corp | Nov 30, 1995 | SESE |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | Cobe Renal Care, Inc. | Sep 8, 1995 | SESE |
| K945622 | MCA(TM) 180 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | May 25, 1995 | SESE |
| K935471 | FILTRYZER(TM) | Toray Industries (America), Inc. | May 19, 1995 | SESE |
| K945631 | 155 SCE(TM) HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | May 18, 1995 | SESE |
| K945624 | MCA(TM) 160 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | May 18, 1995 | SESE |
| K945623 | MCA(TM) 130 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | May 18, 1995 | SESE |
| K941708 | COBE CENTRYSYSTEM CS500 DIALYZER | C.G.H. Medical, Inc. | May 12, 1995 | SESE |
| K940910 | FILTRYZER | Toray Industries (America), Inc. | May 4, 1995 | SESE |
| K950454 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | Apr 27, 1995 | SESE |
| K930503 | CLIRANS WET PACK HOLLOW FIBER DIALYZER | Terumo Medical Corp. | Mar 6, 1995 | SESE |
| K926372 | MCA 200 HEMPDIALYZER | Althin Medical AB an Affiliate of Baxter Intl | Feb 13, 1995 | SESE |
| K926567 | BAXTER CA DIALYZER | Baxter Healthcare Corp | Jan 11, 1995 | SESE |
| K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS | Fresenius USA, Inc. | Aug 23, 1994 | SESE |
| K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R | National Medical Care, Medical Products Div., Inc. | Mar 5, 1993 | SESE |
| K905779 | ALDETECT | Pochemco, Inc. | May 23, 1991 | SESE |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | Cobe Laboratories, Inc. | Dec 12, 1990 | SESE |
| K905228 | MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ | Baxter Healthcare Corp | Dec 10, 1990 | SESE |
| K903567 | BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. | Organon Teknika Corp. | Sep 24, 1990 | SESE |
| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | Gambro, Inc. | Jul 27, 1990 | SESE |
| K893677 | HOLLOW FIBER DIALYZER FOCUS 70H | National Medical Care, Medical Products Div., Inc. | Jul 24, 1989 | SESE |
| K891477 | CLIRANS HOLLOW FIBER HEMODIALYZER (WET) | Terumo Medical Corp. | Jun 9, 1989 | SESE |
| K892375 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | May 18, 1989 | SESE |
| K892374 | NEW AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | May 18, 1989 | SESE |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | Gambro, Inc. | May 11, 1989 | SESE |
| K884339 | TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | Mar 17, 1989 | SESE |
| K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER | Gambro, Inc. | Feb 8, 1989 | SESE |
| K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS | Kawasumi Laboratories Co., Ltd. | Jan 31, 1989 | SESE |
| K883644 | CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 | Baxter Healthcare Corp | Oct 21, 1988 | SESE |
| K883534 | CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 | Baxter Healthcare Corp | Oct 21, 1988 | SESE |
| K883589 | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER | Gambro, Inc. | Sep 29, 1988 | SESE |
| K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS | Cobe Laboratories, Inc. | Sep 15, 1988 | SESE |
| K882158 | MODIFIED TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | Aug 12, 1988 | SESE |
| K882680 | ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA | Baxter Healthcare Corp | Jul 22, 1988 | SESE |
| K882339 | BIO*NEPHROSS I.Q. ANDANTE | Organon Teknika Corp. | Jun 28, 1988 | SESE |
| K882215 | NEPHROSS I.Q. MODERATO | Organon Teknika Corp. | Jun 28, 1988 | SESE |
| K882213 | NEPHROSS I.Q. ALLEGO | Organon Teknika Corp. | Jun 28, 1988 | SESE |
| K880084 | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS | Gambro, Inc. | Feb 19, 1988 | SESE |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | Seratronics, Inc. | Feb 19, 1988 | SESE |
| K874728 | CAPILLARY FLOW DIALYZERS | Baxter Healthcare Corp | Jan 29, 1988 | SESE |
| K874549 | NEPHROSS I.Q. ANDANTE | Organon Teknika Corp. | Jan 29, 1988 | SESE |
| K880083 | GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS | Gambro, Inc. | Jan 27, 1988 | SESE |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Travenol Laboratories, S.A. | Jun 12, 1987 | SESE |
| K871236 | HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H | National Medical Care, Medical Products Div., Inc. | May 29, 1987 | SESE |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | Seratronics, Inc. | May 1, 1987 | SESE |
| K870169 | CAPILLARY FLOW DIALYZERS | Travenol Laboratories, S.A. | Apr 6, 1987 | SESE |
| K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS | Cobe Laboratories, Inc. | Mar 27, 1987 | SESE |
| K863044 | CAPILLARY FLOW HOLLOW FIBER DIALYZERS | National Medical Care, Medical Products Div., Inc. | Mar 27, 1987 | SESE |
| K863592 | DISSCAP 80E, 110E, 140E, 160E | Hospal Medical Corp. | Sep 25, 1986 | SESE |
| K862693 | TORAY FILTRYZER DIALYZER, B1-2.0. | National Medical Care, Medical Products Div., Inc. | Jul 22, 1986 | SESE |
| K861916 | ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER | National Medical Care, Medical Products Div., Inc. | Jul 10, 1986 | SESE |
| K861537 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 | National Medical Care, Medical Products Div., Inc. | Jul 10, 1986 | SESE |
| K861536 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 | National Medical Care, Medical Products Div., Inc. | Jul 10, 1986 | SESE |
| K855212 | ASAHI AM SERIES DIALYZERS | Advocacy International, Ltd. | Jan 21, 1986 | SESE |
| K854280 | CLIRANS TAF HOLLOW FIBER DIALYZER | Terumo Medical Corp. | Dec 13, 1985 | SESE |
| K854575 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | Dec 2, 1985 | SESE |
| K853591 | DIALYZER, CAPILLARY, HOLLOW FIBER | Organon Teknika Corp. | Sep 11, 1985 | SESE |
| K851380 | DISSCAP 110 DIALYZER | Hospal Medical Corp. | Apr 25, 1985 | SESE |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | Erika, Inc. | Apr 3, 1985 | SESE |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | Erika, Inc. | Mar 7, 1985 | SESE |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | Erika, Inc. | Mar 7, 1985 | SESE |
| K820524 | CLIRANS HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | Jul 8, 1982 | SESE |
| K821587 | ERIKA HPF 50 DIALYZER | Erika, Inc. | Jun 25, 1982 | SESE |
| K820743 | HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | Jun 23, 1982 | SESE |
| K821690 | ERIKA HPF 100,200,300 DIALYZER | Erika, Inc. | Jun 22, 1982 | SESE |
| K820304 | GAMBRO GF-80-M, GF-80-H HEMODIALYZER | Gambro, Inc. | Mar 2, 1982 | SESE |
| K812353 | KF-E SERIES OF HOLLOW FIBER DIALYZERS | Medisystems Corp. | Sep 16, 1981 | SESE |
| K802894 | CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY | Cordis Corp. | Feb 19, 1981 | SESE |
| K802893 | CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY | Cordis Corp. | Feb 13, 1981 | SESE |
| K802613 | C-PAK MODEL 12 ARTIFICIAL KIDNEY | Cordis Corp. | Jan 7, 1981 | SESE |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Dec 18, 1980 | SESE |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Dec 18, 1980 | SESE |
| K802114 | NEPHROSS DIALYZER | Organon Teknika Corp. | Dec 18, 1980 | SESE |
| K802092 | HF-100 DIALYZER | Bio-Med Corp. | Dec 18, 1980 | SESE |
| K802466 | DISSCAP HOLLOW FIBER DIALYZER | Hospal Medical Corp. | Nov 12, 1980 | SESE |
| K801559 | HOLLO FIBER DIALYZER | Renal Devices, Inc. | Oct 31, 1980 | SESE |
| K801827 | RENAFLO HOLLOW FIBER DIALYZER #100.1 | Renal Systems, Inc. | Sep 26, 1980 | SESE |
| K801826 | RENAFLO HOLLOW FIBER DIALYZERS #MP 140 | Renal Systems, Inc. | Sep 26, 1980 | SESE |
| K801825 | RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. | Renal Systems, Inc. | Sep 26, 1980 | SESE |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Aug 12, 1980 | SESE |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Aug 12, 1980 | SESE |
| K801178 | COBE HF80, CAT. #18-580 | Cobe Laboratories, Inc. | Jul 28, 1980 | SESE |
| K801370 | GF-120-L DIALYZER | Gambro, Inc. | Jul 21, 1980 | SESE |
| K801344 | EXTRACORPOREALS' ALTERNATE MEMBRANE | Extracorporeal Medical Specialities, Inc. | Jul 21, 1980 | SESE |
| K801045 | GF120H DIALYZER | Gambro, Inc. | Jun 30, 1980 | SESE |
| K800704 | C-DAK TM 2800 ARTIFICIAL KIDNEY | Cordis Corp. | May 8, 1980 | SESE |
| K800336 | GAMBRO LUNDIA FIBER | Gambro, Inc. | May 2, 1980 | SESE |
| K800549 | MODEL TRIEX-L HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | Apr 10, 1980 | SESE |
| K800270 | TRIEX-2 HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | Feb 26, 1980 | SESE |
| K800221 | CF/211 CAPILLARY FLOW DIALYZER, #5M1784 | Travenol Laboratories, S.A. | Feb 26, 1980 | SESE |
| K792419 | C-DAK 2100 ARTIFICIAL KIDNEY | Cordis Corp. | Jan 16, 1980 | SESE |
| K791322 | ERIKA HPF 300 | Erika, Inc. | Sep 24, 1979 | SESE |
| K791321 | ERIKA HPF 200 | Erika, Inc. | Sep 24, 1979 | SESE |
| K791320 | ERIKA HPF 100 | Erika, Inc. | Sep 24, 1979 | SESE |
| K790696 | RDI-1 HOLLOW FIBER DIALYZER | Renal Devices, Inc. | Jun 20, 1979 | SESE |
| K790308 | DISPOSABLE DIALYZERS, SD-ID, SD-2D | Bentley Laboratories, Inc. | May 1, 1979 | SESE |
| K790067 | FLOW DIALYZER, CF 2300 CAPILLARY | Travenol Laboratories, S.A. | Apr 10, 1979 | SESE |
| K782151 | ARTIFICIAL KIDNEY, C-DAK 0.6D | Cordis Corp. | Feb 22, 1979 | SESE |
| K781142 | DISSCAP | Hospal Medical Corp. | Sep 14, 1978 | SESE |
| K781058 | C-DAK 4000 ARTIFICIAL KIDNEY | Cordis Corp. | Aug 23, 1978 | SESE |
| K772290 | DIALYZER, CAPILATORY, HOLLOW FIBER | Redy Laboratories | Mar 15, 1978 | SESE |
| K772423 | SPIRAFLOW DIALYZERS | Bentley Laboratories, Inc. | Jan 26, 1978 | SESE |
| K771694 | CLIRANS TH 15 HOLLOW FIBER DIALYZER | Terumo America, Inc. | Sep 15, 1977 | SESE |
| K770867 | DIALYZER, FIBER, HOLLOW | Cobe Laboratories, Inc. | Jun 14, 1977 | SESE |
| K770734 | DIALYZER, FIBER, HOLLOW | Travenol Laboratories, S.A. | May 10, 1977 | SESE |
| K761007 | ARTIFICIAL KIDNEY, C-DAK CORDIS DOW | Cordis Corp. | Jan 12, 1977 | SESE |
| K760252 | DIALYZER, HF 130 HOLLOW FIBER | Cobe Laboratories, Inc. | Oct 15, 1976 | SESE |
Top Applicants
- Gambro, Inc. — 10 clearances
- National Medical Care, Medical Products Div., Inc. — 9 clearances
- Baxter Healthcare Corp — 9 clearances
- Erika, Inc. — 8 clearances
- Cordis Corp. — 8 clearances
