Product code FKX

Device name: System, Peritoneal, Automatic Delivery
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.5630
Review panel: GU
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250523	Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (...	Simergent, LLC	2025-10-02
K243371	Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1	Byonyks Pvt, Ltd.	2025-05-16
K220935	Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App	Iren-Medical, Ltd.	2022-12-29
K222318	Fresenius Liberty Select Cycler	Fresenius Medical Care Renal Therapies Group, LLC	2022-10-31
K212522	Lilliput APD System	Fresenius Medical Care Renal Therapies Group, LLC	2022-04-15
K212658	CloudCath Peritoneal Dialysis Drain Set Monitoring System	Cloudcath	2022-02-09
K201867	Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System	Baxter Healthcare Corporation	2020-11-19
K181108	Fresenius Liberty Select Cycler	Fresenius Medical Care Renal Therapies Group, LLC	2018-05-24
K173718	Liberty Cycler Set	Fresenius Medical Care Renal Therapies Group, LLC	2018-05-01
K171652	Fresenius Liberty Select Cycler	Fresenius Medical Care Renal Therapies Group, LLC	2017-09-15
K151525	Amia Automated PD System with Sharesource	Deka Research and Development	2015-10-09
K141145	LIBERTY PDX CYCLER	Fresenius Medical Care Renal Therapies Group, LLC	2014-07-30
K123630	FRESENIUS LIBERTY CYCLER	Fresenius Medical Care North America, Design Cente	2013-09-09
K124018	AMIA AUTOMATED PD SYSTEM	Deka Research & Development Corp.	2013-06-14
K103220	VOYAGER PERITONEAL DIALYSIS SYSTEM	Deka Research & Development Corp.	2011-07-29
K102936	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R	Baxter Healthcare Corp	2011-03-30
K053512	HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310	Baxter Healthcare Corp	2006-02-16
K043363	FRESENIUS LIBERTY CYCLER	Fresenius Medical Care North America	2005-03-31
K012988	HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469	Baxter Healthcare Corp	2001-12-05
K002892	FRSENIUS PD IQCARD CYCLER	Fresenius Medical Care North America	2001-04-05
K994218	EASY CARE AND TUBING SETS	Medionics International, Inc.	2000-02-10
K935659	BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST	Baxter Healthcare Corp	1994-07-07
K923065	BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL	Baxter Healthcare Corp	1994-03-04
K933687	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	R & D Batteries, Inc.	1994-02-09
K905809	NMC CYCLER MACHINE	National Medical Care, Medical Products Div., Inc.	1992-02-25
K910173	SELECTRA AND TUBING SETS	Medionics International , Ltd.	1992-01-13
K902149	FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM	Fresenius/Delmed, Inc.	1990-10-30
K901477	DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION	Delmed, Inc.	1990-07-27
K901478	DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION	Delmed, Inc.	1990-07-27
K901228	MULTI-STRIP	Bellhouse Medical, Inc.	1990-05-07

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00085412030531	NA	Baxter Healthcare SA	2025-08-28
00840861102235	VersiPD	Fresenius Medical Care Holdings, Inc.	2023-02-14
00840861102228	VersiPD	Fresenius Medical Care Holdings, Inc.	2023-02-14
00840861102211	VersiPD	Fresenius Medical Care Holdings, Inc.	2023-02-14
00085412676463	Homechoice Claria	BAXTER HEALTHCARE CORPORATION	2020-12-01
45413765565692	Sharesource Connectivity Platform	BAXTER INTERNATIONAL INC.	2020-09-20
55413765565699	Sharesource Connectivity Platform	BAXTER INTERNATIONAL INC.	2020-09-20
35413765565695	Sharesource Connectivity Platform	BAXTER INTERNATIONAL INC.	2019-06-01
00840861102303	stay•safe® organizer holder	Fresenius Medical Care Holdings, Inc.	2019-05-09
00085412050829	Easy-Lock	BAXTER HEALTHCARE CORPORATION	2018-11-14
00085412153186	Amia Automated PD Set with Cassette	BAXTER INTERNATIONAL INC.	2015-10-12
00840861100675	Premier	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861101993	Liberty® PDx	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861101986	Liberty® PDx	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861101979	Liberty® PDx	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861101115	Liberty®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100750	Liberty®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100743	Liberty®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100736	Liberty®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100682	Premier	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100651	Safe-Lock®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00840861100620	Liberty®	Fresenius Medical Care Holdings, Inc.	2015-10-02
00085412007670	Empty Sterile Container	BAXTER INTERNATIONAL INC.	2015-09-24
00085412030555	Extension Set	BAXTER INTERNATIONAL INC.	2015-09-24
00085412007717	Effluent Sample Bag	BAXTER INTERNATIONAL INC.	2015-09-24
00085412087405	LOW RECIRCULATION VOLUME APD SET	BAXTER INTERNATIONAL INC.	2015-09-24
00085412087375	HOMECHOICE APD SET	BAXTER INTERNATIONAL INC.	2015-09-24
00085412090078	INTERGRATED APD SET	BAXTER INTERNATIONAL INC.	2015-09-24
00085412088433	AUTOMATED PD SET	BAXTER INTERNATIONAL INC.	2015-09-24
00085412087672	LOW RECIRCULATION VOLUME APD SET	BAXTER INTERNATIONAL INC.	2015-09-24

Product code FKX

Related 510(k) Records#

Related GUDID Devices#