Product code KPF— Gastroenterology, Urology
AMICON EQUALINE FLUID BALANCE SYSTEM
- Classification name
- System, Dialysate Delivery, Semi-Automatic, Peritoneal
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code KPF
FDA has cleared devices under product code KPF between 1979 and 2006, filed by 10 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.
Clearances per year
- 2006
- 1999
- 1997
- 1996
- 1994
- 1988
- 1982
- 1980
- 1979
Top applicants under product code KPF
Recent clearances under product code KPF
- K061515 — RENALSOFT
- K990953 — RENAL LINK
- K970989 — CYBERREN
- K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
- K913515 — TOTAL CONTAINMENT DEVICE
- K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM
- K874020 — ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
- K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP
- K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR
- K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER
- K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000
- K791584 — CYLER/HEATER FOR PERITONEAL DIALYSIS
- K790091 — AMP AUTOMATIC CYCLER STAND
Data sourced from openFDA. This site is unofficial and independent of the FDA.