FJI · Class II · 21 CFR 876.5820

FDA Product Code FJI: Dialyzer, Capillary, Hollow Fiber

Leading manufacturers include Gambro, Inc., National Medical Care, Medical Products Div., Inc. and Baxter Healthcare Corp.

131
Total
131
Cleared
127d
Avg days
1976
Since

FDA 510(k) Cleared Dialyzer, Capillary, Hollow Fiber Devices (Product Code FJI)

131 devices
1–24 of 131
Cleared Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
K190459
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 178d
Cleared Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
K122952
Nipro Medical Corporation
Gastroenterology & Urology · 435d
Cleared May 27, 2005
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
K043342
Gambro Renal Products
Gastroenterology & Urology · 172d
Cleared Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
K011148
Interpore Cross Intl.
Gastroenterology & Urology · 58d
Cleared Dec 04, 2000
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761
Fresenius Medical Care North America
Gastroenterology & Urology · 90d
Cleared Apr 17, 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908
Idemsa
Gastroenterology & Urology · 315d
Cleared Sep 24, 1999
A-15 HEMODIALYZER
K992594
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Sep 23, 1999
A-18 HEMODIALYZER
K992565
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Jul 29, 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Apr 19, 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159
Dynamic Technology Corp.
Gastroenterology & Urology · 90d
Cleared Dec 29, 1998
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
K982337
Haidylena Medical Egypt
Gastroenterology & Urology · 176d
Cleared Dec 11, 1998
ULTRACON ULTRAFILTRATOR
K981253
Interpore Intl.
Gastroenterology & Urology · 249d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared Feb 27, 1998
ULTRACON ULTRAFILTRATOR
K971710
Quantic Biomedical, Inc.
Gastroenterology & Urology · 295d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708
Terumo Medical Corp.
Gastroenterology & Urology · 296d
Cleared Dec 19, 1997
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
K973291
Dynamic Technology Corp.
Gastroenterology & Urology · 108d
Cleared Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933
Baxter Healthcare Corp
Gastroenterology & Urology · 419d
Cleared Dec 27, 1996
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
K962309
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 193d
Cleared Sep 12, 1996
BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL
K961039
Dayspring Medical, Inc.
Gastroenterology & Urology · 182d
Cleared Jun 11, 1996
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
K961040
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 10, 1996
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
K961026
Dayspring Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 29, 1996
COBE CENTRYSYSTEM CS 200 DIALYZER
K944436
Cobe Renal Care, Inc.
Gastroenterology & Urology · 504d
Cleared Dec 22, 1995
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 217d
Cleared May 25, 1995
MCA(TM) 180 HEMODIALYZER
K945622
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 191d

About Product Code FJI - Regulatory Context