FKX — System, Peritoneal, Automatic Delivery Class II

FDA Device Classification

Classification Details

Product Code
FKX
Device Class
Class II
Regulation Number
876.5630
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250523simergentArchimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes SOctober 2, 2025
K243371byonyks pvtByonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1May 16, 2025
K220935iren-medicalDigital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical SupeDecember 29, 2022
K222318fresenius medical care renal therapies groupFresenius Liberty Select CyclerOctober 31, 2022
K212522fresenius medical care renal therapies groupLilliput APD SystemApril 15, 2022
K212658cloudcathCloudCath Peritoneal Dialysis Drain Set Monitoring SystemFebruary 9, 2022
K201867baxter healthcare corporationHomechoice Claria APD System, Sharesource Connectivity Platform for Use with theNovember 19, 2020
K181108fresenius medical care renal therapies groupFresenius Liberty Select CyclerMay 24, 2018
K173718fresenius medical care renal therapies groupLiberty Cycler SetMay 1, 2018
K171652fresenius medical care renal therapies groupFresenius Liberty Select CyclerSeptember 15, 2017
K151525deka research and developmentAmia Automated PD System with SharesourceOctober 9, 2015
K141145fresenius medical care renal therapies groupLIBERTY PDX CYCLERJuly 30, 2014
K123630fresenius medical care north america, design centeFRESENIUS LIBERTY CYCLERSeptember 9, 2013
K124018deka research and developmentAMIA AUTOMATED PD SYSTEMJune 14, 2013
K103220deka research and developmentVOYAGER PERITONEAL DIALYSIS SYSTEMJuly 29, 2011
K102936baxter healthcareHOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MMarch 30, 2011
K053512baxter healthcareHOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4February 16, 2006
K043363fresenius medical care north americaFRESENIUS LIBERTY CYCLERMarch 31, 2005
K012988baxter healthcareHOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5CDecember 5, 2001
K002892fresenius medical care north americaFRSENIUS PD IQCARD CYCLERApril 5, 2001