FDA Product Code
FDA Product Code FJI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 131 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 | Traditional | PDF ↗ |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | Nipro Medical Corporation | 2013-12-04 | Traditional | PDF ↗ |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | Gambro Renal Products | 2005-05-27 | Traditional | PDF ↗ |
| K010366 | DISPOSABLE STORAGE CAP | Molded Products, Inc. | 2001-11-28 | Abbreviated | PDF ↗ |
| K011148 | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | 2001-06-13 | Special | PDF ↗ |
| K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | Fresenius Medical Care North America | 2000-12-04 | Traditional | PDF ↗ |
| K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | 2000-04-17 | Traditional | PDF ↗ |
| K992594 | A-15 HEMODIALYZER | Althin Medical AB | 1999-09-24 | Traditional | PDF ↗ |
| K992565 | A-18 HEMODIALYZER | Althin Medical AB | 1999-09-23 | Traditional | PDF ↗ |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | 1999-07-29 | Traditional | PDF ↗ |
| K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | 1999-04-19 | Traditional | PDF ↗ |
| K982337 | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | Haidylena Medical Egypt | 1998-12-29 | Traditional | PDF ↗ |
| K981253 | ULTRACON ULTRAFILTRATOR | Interpore Intl. | 1998-12-11 | Traditional | PDF ↗ |
| K980658 | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | Baxter Healthcare Corp | 1998-05-19 | Traditional | PDF ↗ |
| K971710 | ULTRACON ULTRAFILTRATOR | Quantic Biomedical, Inc. | 1998-02-27 | Traditional | PDF ↗ |
| K970708 | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 1997-12-19 | Traditional | PDF ↗ |
| K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | 1997-12-19 | Traditional | PDF ↗ |
| K963933 | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | 1997-11-24 | Traditional | PDF ↗ |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 | Traditional | PDF ↗ |
| K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL | Dayspring Medical, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC | Dayspring Medical, Inc. | 1996-06-11 | Traditional | PDF ↗ |
| K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL | Dayspring Medical, Inc. | 1996-06-10 | Traditional | PDF ↗ |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | Cobe Renal Care, Inc. | 1996-01-29 | Traditional | PDF ↗ |
| K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER | National Medical Care, Medical Products Div., Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K950602 | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS | Reprocessing Products Corp | 1995-11-30 | Traditional | PDF ↗ |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | Cobe Renal Care, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K945622 | MCA(TM) 180 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-25 | Traditional | PDF ↗ |
| K935471 | FILTRYZER(TM) | Toray Industries (America), Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K945624 | MCA(TM) 160 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | Traditional | PDF ↗ |
| K945631 | 155 SCE(TM) HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | Traditional | PDF ↗ |
| K945623 | MCA(TM) 130 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | Traditional | PDF ↗ |
| K941708 | COBE CENTRYSYSTEM CS500 DIALYZER | C.G.H. Medical, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K940910 | FILTRYZER | Toray Industries (America), Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K950454 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | 1995-04-27 | Traditional | PDF ↗ |
| K930503 | CLIRANS WET PACK HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K926372 | MCA 200 HEMPDIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | Traditional | PDF ↗ |
| K926567 | BAXTER CA DIALYZER | Baxter Healthcare Corp | 1995-01-11 | Traditional | PDF ↗ |
| K926005 | FRESENIUS HEMOFLOW, VARIOUS MODELS | Fresenius USA, Inc. | 1994-08-23 | Traditional | PDF ↗ |
| K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R | National Medical Care, Medical Products Div., Inc. | 1993-03-05 | Traditional | PDF ↗ |
| K905779 | ALDETECT | Pochemco, Inc. | 1991-05-23 | Traditional | PDF ↗ |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | Cobe Laboratories, Inc. | 1990-12-12 | Traditional | PDF ↗ |
| K905228 | MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ | Baxter Healthcare Corp | 1990-12-10 | Traditional | PDF ↗ |
| K903567 | BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. | Organon Teknika Corp. | 1990-09-24 | Traditional | PDF ↗ |
| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | Gambro, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K893677 | HOLLOW FIBER DIALYZER FOCUS 70H | National Medical Care, Medical Products Div., Inc. | 1989-07-24 | Traditional | PDF ↗ |
| K891477 | CLIRANS HOLLOW FIBER HEMODIALYZER (WET) | Terumo Medical Corp. | 1989-06-09 | Traditional | PDF ↗ |
| K892375 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1989-05-18 | Traditional | PDF ↗ |
| K892374 | NEW AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1989-05-18 | Traditional | PDF ↗ |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | Gambro, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K884339 | TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER | Gambro, Inc. | 1989-02-08 | Traditional | PDF ↗ |
| K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS | Kawasumi Laboratories Co., Ltd. | 1989-01-31 | Traditional | PDF ↗ |
| K883644 | CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 | Baxter Healthcare Corp | 1988-10-21 | Traditional | PDF ↗ |
| K883534 | CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 | Baxter Healthcare Corp | 1988-10-21 | Traditional | PDF ↗ |
| K883589 | GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER | Gambro, Inc. | 1988-09-29 | Traditional | PDF ↗ |
| K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS | Cobe Laboratories, Inc. | 1988-09-15 | Traditional | PDF ↗ |
| K882158 | MODIFIED TORAY FILTRYZER DIALYZERS | Toray Industries (America), Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K882680 | ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA | Baxter Healthcare Corp | 1988-07-22 | Traditional | PDF ↗ |
| K882213 | NEPHROSS I.Q. ALLEGO | Organon Teknika Corp. | 1988-06-28 | Traditional | PDF ↗ |
| K882339 | BIO*NEPHROSS I.Q. ANDANTE | Organon Teknika Corp. | 1988-06-28 | Traditional | PDF ↗ |
| K882215 | NEPHROSS I.Q. MODERATO | Organon Teknika Corp. | 1988-06-28 | Traditional | PDF ↗ |
| K880084 | GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS | Gambro, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | Seratronics, Inc. | 1988-02-19 | Traditional | PDF ↗ |
| K874728 | CAPILLARY FLOW DIALYZERS | Baxter Healthcare Corp | 1988-01-29 | Traditional | PDF ↗ |
| K874549 | NEPHROSS I.Q. ANDANTE | Organon Teknika Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K880083 | GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS | Gambro, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Travenol Laboratories, S.A. | 1987-06-12 | Traditional | PDF ↗ |
| K871236 | HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H | National Medical Care, Medical Products Div., Inc. | 1987-05-29 | Traditional | PDF ↗ |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | Seratronics, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K870169 | CAPILLARY FLOW DIALYZERS | Travenol Laboratories, S.A. | 1987-04-06 | Traditional | PDF ↗ |
| K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS | Cobe Laboratories, Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K863044 | CAPILLARY FLOW HOLLOW FIBER DIALYZERS | National Medical Care, Medical Products Div., Inc. | 1987-03-27 | Traditional | PDF ↗ |
| K863592 | DISSCAP 80E, 110E, 140E, 160E | Hospal Medical Corp. | 1986-09-25 | Traditional | PDF ↗ |
| K862693 | TORAY FILTRYZER DIALYZER, B1-2.0. | National Medical Care, Medical Products Div., Inc. | 1986-07-22 | Traditional | PDF ↗ |
| K861916 | ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER | National Medical Care, Medical Products Div., Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K861537 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 | National Medical Care, Medical Products Div., Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K861536 | ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 | National Medical Care, Medical Products Div., Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K855212 | ASAHI AM SERIES DIALYZERS | Advocacy International, Ltd. | 1986-01-21 | Traditional | PDF ↗ |
| K854280 | CLIRANS TAF HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1985-12-13 | Traditional | PDF ↗ |
| K854575 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1985-12-02 | Traditional | PDF ↗ |
| K853591 | DIALYZER, CAPILLARY, HOLLOW FIBER | Organon Teknika Corp. | 1985-09-11 | Traditional | PDF ↗ |
| K851380 | DISSCAP 110 DIALYZER | Hospal Medical Corp. | 1985-04-25 | Traditional | PDF ↗ |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | Erika, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | Erika, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | Erika, Inc. | 1985-03-07 | Traditional | PDF ↗ |
| K820524 | CLIRANS HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 1982-07-08 | Traditional | PDF ↗ |
| K821587 | ERIKA HPF 50 DIALYZER | Erika, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K820743 | HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 1982-06-23 | Traditional | PDF ↗ |
| K821690 | ERIKA HPF 100,200,300 DIALYZER | Erika, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K820304 | GAMBRO GF-80-M, GF-80-H HEMODIALYZER | Gambro, Inc. | 1982-03-02 | Traditional | PDF ↗ |
| K812353 | KF-E SERIES OF HOLLOW FIBER DIALYZERS | Medisystems Corp. | 1981-09-16 | Traditional | PDF ↗ |
| K802894 | CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY | Cordis Corp. | 1981-02-19 | Traditional | PDF ↗ |
| K802893 | CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY | Cordis Corp. | 1981-02-13 | Traditional | PDF ↗ |
| K802613 | C-PAK MODEL 12 ARTIFICIAL KIDNEY | Cordis Corp. | 1981-01-07 | Traditional | PDF ↗ |
| K802114 | NEPHROSS DIALYZER | Organon Teknika Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802092 | HF-100 DIALYZER | Bio-Med Corp. | 1980-12-18 | Traditional | PDF ↗ |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Terumo America, Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Terumo America, Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K802466 | DISSCAP HOLLOW FIBER DIALYZER | Hospal Medical Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K801559 | HOLLO FIBER DIALYZER | Renal Devices, Inc. | 1980-10-31 | Traditional | PDF ↗ |
Product code FJI · Class II · Gastroenterology, Urology. Data: openFDA.