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 |
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 |
liberDi, 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 |