FKR — Subsystem, Proportioning Class II

FDA Device Classification

Classification Details

Product Code
FKR
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140571nxstage medicalNXSTAGE PUREFLOW SLMay 15, 2014
K111174nxstage medicalNXSTAGE PUREFLOW SLSeptember 19, 2011
K080919nxstage medicalNXSTAGE PUREFLOW SLOctober 15, 2008
K060296nxstage medicalNXSTAGE DIALYSATE PREPARATION MODULEMarch 31, 2006
K043436nxstage medicalNXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269March 17, 2005
K850435sartorius filtersSARTORIUS AQUASART SM 40035 - DIALYSATE SYSJune 4, 1985
K850756travenol laboratoriesAUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSMarch 20, 1985
K810605trimedyneCHEMATIC BICARBONATE DIALYSATE SYSTEMJune 16, 1981
K810127gambroGAMBRO BICARBONATE MODULE, BCM-10February 25, 1981
K802465renal systemsBICARB-O-MATE HEMODIALYSIS SOD. BICARB.November 12, 1980
K800772extracorporeal medical specialitiesMOD. DM-357 BICARBONATE RETROFIT KITMay 14, 1980
K781303bd becton dickinson vacutainer systems preanalyticBIO-PRO UNITOctober 2, 1978