FKR · Class II · 21 CFR 876.5820

FDA Product Code FKR: Subsystem, Proportioning

Leading manufacturers include Nxstage Medical, Inc., Gambro, Inc. and Trimedyne, Inc..

12
Total
12
Cleared
82d
Avg days
1978
Since

FDA 510(k) Cleared Subsystem, Proportioning Devices (Product Code FKR)

12 devices
1–12 of 12
Cleared May 15, 2014
NXSTAGE PUREFLOW SL
K140571
Nxstage Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Sep 19, 2011
NXSTAGE PUREFLOW SL
K111174
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Oct 15, 2008
NXSTAGE PUREFLOW SL
K080919
Nxstage Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Mar 31, 2006
NXSTAGE DIALYSATE PREPARATION MODULE
K060296
Nxstage Medical, Inc.
Gastroenterology & Urology · 53d
Cleared Mar 17, 2005
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
K043436
Nxstage Medical, Inc.
Gastroenterology & Urology · 94d
Cleared Mar 20, 1985
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS
K850756
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jun 16, 1981
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605
Trimedyne, Inc.
Gastroenterology & Urology · 102d
Cleared Feb 25, 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127
Gambro, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 12, 1980
BICARB-O-MATE HEMODIALYSIS SOD. BICARB.
K802465
Renal Systems, Inc.
Gastroenterology & Urology · 34d
Cleared May 14, 1980
MOD. DM-357 BICARBONATE RETROFIT KIT
K800772
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 37d
Cleared Oct 02, 1978
BIO-PRO UNIT
K781303
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 67d

About Product Code FKR - Regulatory Context