FDA 510(k) Applications for Medical Device Product Code "FKX"
(System, Peritoneal, Automatic Delivery)

FDA 510(k) Number Applicant Device Name Decision Date
K012988 BAXTER HEALTHCARE CORP. HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 12/05/2001
K102936 BAXTER HEALTHCARE CORP. HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R 03/30/2011
K053512 BAXTER HEALTHCARE CORP. HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 02/16/2006
K201867 Baxter Healthcare Corporation Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System 11/19/2020
K243371 Byonyks Pvt Ltd Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 05/16/2025
K212658 CloudCath CloudCath Peritoneal Dialysis Drain Set Monitoring System 02/09/2022
K124018 DEKA RESEARCH & DEVELOPMENT CORP. AMIA AUTOMATED PD SYSTEM 06/14/2013
K103220 DEKA RESEARCH & DEVELOPMENT CORP. VOYAGER PERITONEAL DIALYSIS SYSTEM 07/29/2011
K151525 DEKA RESEARCH AND DEVELOPMENT Amia Automated PD System with Sharesource 10/09/2015
K043363 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS LIBERTY CYCLER 03/31/2005
K002892 FRESENIUS MEDICAL CARE NORTH AMERICA FRSENIUS PD IQCARD CYCLER 04/05/2001
K123630 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE FRESENIUS LIBERTY CYCLER 09/09/2013
K171652 Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Select Cycler 09/15/2017
K181108 Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Select Cycler 05/24/2018
K222318 Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Select Cycler 10/31/2022
K173718 Fresenius Medical Care Renal Therapies Group, LLC Liberty Cycler Set 05/01/2018
K141145 FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC LIBERTY PDX CYCLER 07/30/2014
K212522 Fresenius Medical Care Renal Therapies Group, LLC Lilliput APD System 04/15/2022
K220935 iRen-Medical, Ltd Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App 12/29/2022
K994218 MEDIONICS INTERNATIONAL, INC. EASY CARE AND TUBING SETS 02/10/2000


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