FKX · Class II · 21 CFR 876.5630

FDA Product Code FKX: System, Peritoneal, Automatic Delivery

Leading manufacturers include American Medical Products, Inc., Travenol Laboratories, S.A. and Baxter Healthcare Corp.

83
Total
83
Cleared
106d
Avg days
1977
Since
83 devices
25–48 of 83
Cleared Feb 25, 1992
NMC CYCLER MACHINE
K905809
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 425d
Cleared Jan 13, 1992
SELECTRA AND TUBING SETS
K910173
Medionics International , Ltd.
Gastroenterology & Urology · 363d
Cleared Oct 30, 1990
FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
K902149
Fresenius/Delmed, Inc.
Gastroenterology & Urology · 168d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION
K901477
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared Jul 27, 1990
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K901478
Delmed, Inc.
Gastroenterology & Urology · 122d
Cleared May 07, 1990
MULTI-STRIP
K901228
Bellhouse Medical, Inc.
Gastroenterology & Urology · 54d
Cleared Nov 28, 1989
ABBOTT INPERSOL CYCLER 1000
K895336
Abbott Laboratories
Gastroenterology & Urology · 89d
Cleared Jan 31, 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554
Baxter Healthcare Corp
Gastroenterology & Urology · 92d
Cleared Dec 29, 1987
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652
Travenol Laboratories, S.A.
Gastroenterology & Urology · 85d
Cleared Mar 09, 1987
AMUKIN-50% FOR CAPD Y-SET
K862928
Amuchina Intl., Inc.
Gastroenterology & Urology · 220d
Cleared Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Mar 12, 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630
Organon Teknika Corp.
Gastroenterology & Urology · 105d
Cleared Feb 21, 1985
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406
Travenol Laboratories, S.A.
Gastroenterology & Urology · 17d
Cleared Jan 07, 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
K844108
Renal Systems, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 16, 1984
SCD STERILE CONNECTION DEVICE
K844144
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 24d
Cleared Oct 18, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885
Travenol Laboratories, S.A.
Gastroenterology & Urology · 87d
Cleared Aug 08, 1984
LIFEMED LIFECOIL CATHETERS
K841929
Lifemed of California
Gastroenterology & Urology · 90d
Cleared Jun 25, 1984
C.A.P.D. AUTOMATIC HEATER PDH 200
K842305
Medionics International , Ltd.
Gastroenterology & Urology · 13d
Cleared Feb 21, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224
Travenol Laboratories, S.A.
Gastroenterology & Urology · 33d
Cleared Dec 27, 1983
PERITONEAL CATHETER-CHANGES-
K833749
Quinton, Inc.
Gastroenterology & Urology · 62d
Cleared Nov 29, 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared Nov 28, 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065
Travenol Laboratories, S.A.
Gastroenterology & Urology · 81d
Cleared Oct 14, 1983
MICROSTAR VCI
K831766
Medionics International , Ltd.
Gastroenterology & Urology · 135d