Product code FKR— Gastroenterology, Urology

FDA has cleared 12 devices under product code FKR between 1978 and 2014, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20141 clearance
• 20111 clearance
• 20081 clearance
• 20061 clearance
• 20051 clearance
• 19852 clearances
• 19812 clearances
• 19802 clearances
• 19781 clearance

• Nxstage Medical, Inc.5 clearances
• Trimedyne, Inc.1 clearance
• Travenol Laboratories, S.A.1 clearance
• Sartorius Filters, Inc.1 clearance
• Renal Systems, Inc.1 clearance
• Gambro, Inc.1 clearance
• Extracorporeal Medical Specialities, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance

• K140571 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·2014-05-15
• K111174 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·2011-09-19
• K080919 — NXSTAGE PUREFLOW SLNxstage Medical, Inc.·2008-10-15
• K060296 — NXSTAGE DIALYSATE PREPARATION MODULENxstage Medical, Inc.·2006-03-31
• K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269Nxstage Medical, Inc.·2005-03-17
• K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYSSartorius Filters, Inc.·1985-06-04
• K850756 — AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSTravenol Laboratories, S.A.·1985-03-20
• K810605 — CHEMATIC BICARBONATE DIALYSATE SYSTEMTrimedyne, Inc.·1981-06-16
• K810127 — GAMBRO BICARBONATE MODULE, BCM-10Gambro, Inc.·1981-02-25
• K802465 — BICARB-O-MATE HEMODIALYSIS SOD. BICARB.Renal Systems, Inc.·1980-11-12
• K800772 — MOD. DM-357 BICARBONATE RETROFIT KITExtracorporeal Medical Specialities, Inc.·1980-05-14
• K781303 — BIO-PRO UNITBd Becton Dickinson Vacutainer Systems Preanalytic·1978-10-02