Product Code: FKX FDA class 2 21 CFR 876.5630

System, Peritoneal, Automatic Delivery

Gastroenterology, Urology

The Automatic Peritoneal Delivery System is a device that mechanically controls the infusion and drainage of dialysate fluid into and out of the peritoneal cavity during automated peritoneal dialysis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKX, regulated under 21 CFR 876.5630 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FKX
Device Class: FDA class 2
Regulation Number: 876.5630
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 83 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
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 (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)	Oct 02, 2025	Substantially Equivalent	Simergent, LLC
K243371	Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1	May 16, 2025	Substantially Equivalent	Byonyks Pvt, Ltd.
K220935	Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App	Dec 29, 2022	Substantially Equivalent	Iren-Medical, Ltd.
K222318	Fresenius Liberty Select Cycler	Oct 31, 2022	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K212522	Lilliput APD System	Apr 15, 2022	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K212658	CloudCath Peritoneal Dialysis Drain Set Monitoring System	Feb 09, 2022	Substantially Equivalent	Cloudcath
K201867	Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System	Nov 19, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K181108	Fresenius Liberty Select Cycler	May 24, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K173718	Liberty Cycler Set	May 01, 2018	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K171652	Fresenius Liberty Select Cycler	Sep 15, 2017	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K151525	Amia Automated PD System with Sharesource	Oct 09, 2015	Substantially Equivalent	Deka Research and Development
K141145	LIBERTY PDX CYCLER	Jul 30, 2014	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K123630	FRESENIUS LIBERTY CYCLER	Sep 09, 2013	Substantially Equivalent	Fresenius Medical Care North America, Design Cente
K124018	AMIA AUTOMATED PD SYSTEM	Jun 14, 2013	Substantially Equivalent	Deka Research & Development Corp.
K103220	VOYAGER PERITONEAL DIALYSIS SYSTEM	Jul 29, 2011	Substantially Equivalent	Deka Research & Development Corp.
K102936	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R	Mar 30, 2011	Substantially Equivalent	Baxter Healthcare Corp
K053512	HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310	Feb 16, 2006	Substantially Equivalent	Baxter Healthcare Corp
K043363	FRESENIUS LIBERTY CYCLER	Mar 31, 2005	Substantially Equivalent	Fresenius Medical Care North America
K012988	HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469	Dec 05, 2001	Substantially Equivalent	Baxter Healthcare Corp
K002892	FRSENIUS PD IQCARD CYCLER	Apr 05, 2001	Substantially Equivalent	Fresenius Medical Care North America
K994218	EASY CARE AND TUBING SETS	Feb 10, 2000	Substantially Equivalent	Medionics International, Inc.
K935659	BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST	Jul 07, 1994	Substantially Equivalent	Baxter Healthcare Corp
K923065	BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL	Mar 04, 1994	Substantially Equivalent	Baxter Healthcare Corp
K933687	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	Feb 09, 1994	Substantially Equivalent	R & D Batteries, Inc.
K905809	NMC CYCLER MACHINE	Feb 25, 1992	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K910173	SELECTRA AND TUBING SETS	Jan 13, 1992	Substantially Equivalent	Medionics International , Ltd.
K902149	FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM	Oct 30, 1990	Substantially Equivalent	Fresenius/Delmed, Inc.
K901478	DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION	Jul 27, 1990	Substantially Equivalent	Delmed, Inc.
K901477	DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION	Jul 27, 1990	Substantially Equivalent	Delmed, Inc.
K901228	MULTI-STRIP	May 07, 1990	Substantially Equivalent	Bellhouse Medical, Inc.
K895336	ABBOTT INPERSOL CYCLER 1000	Nov 28, 1989	Substantially Equivalent	Abbott Laboratories
K884554	PERITONEAL CATHETER STABILIZATION DEVICE 5C4381	Jan 31, 1989	Substantially Equivalent	Baxter Healthcare Corp
K874632	BENT NECK CURLCATH PERITONEAL DIALYSIS KIT	Dec 29, 1987	Substantially Equivalent	Quinton, Inc.
K872652	UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM	Sep 30, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K862928	AMUKIN-50% FOR CAPD Y-SET	Mar 09, 1987	Substantially Equivalent	Amuchina Intl., Inc.
K845042	ABBOTT INPERSOL CYCLER 1000	Mar 19, 1985	Substantially Equivalent	Abbott Laboratories
K844630	ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM	Mar 12, 1985	Substantially Equivalent	Organon Teknika Corp.
K850406	AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM	Feb 21, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K844108	RENAL SYSTEMS PERITONEAL ACCESS SYSTEM	Jan 07, 1985	Substantially Equivalent	Renal Systems, Inc.
K844144	SCD STERILE CONNECTION DEVICE	Nov 16, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K842885	EXTENDED LIFE CAPD SOLUTION TRANSFER	Oct 18, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K841929	LIFEMED LIFECOIL CATHETERS	Aug 08, 1984	Substantially Equivalent	Lifemed of California
K842305	C.A.P.D. AUTOMATIC HEATER PDH 200	Jun 25, 1984	Substantially Equivalent	Medionics International , Ltd.
K840224	EXTENDED LIFE CAPD SOLUTION TRANSFER	Feb 21, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K833749	PERITONEAL CATHETER-CHANGES-	Dec 27, 1983	Substantially Equivalent	Quinton, Inc.
K833595	CAPD ULTRAVIOLET GERMICIDAL EXCHANGE	Nov 29, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K833065	AUTOMATIC PERITONEAL DIALYSIS CYCLER	Nov 28, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K832141	MICROSTAR VC1 VOLUMETRIC CYCLER	Oct 14, 1983	Substantially Equivalent	Medionics International , Ltd.
K831766	MICROSTAR VCI	Oct 14, 1983	Substantially Equivalent	Medionics International , Ltd.
K831716	CAPD - CATHETER ADAPTER	Jun 24, 1983	Substantially Equivalent	American Mcgaw
K830881	AMPERCIDE DISINFECTANT ACCESSORY TO -	Jun 02, 1983	Substantially Equivalent	American Medical Products, Inc.
K830766	ABBOTT PATIENT ASSIST DEVICE	Mar 29, 1983	Substantially Equivalent	Abbott Laboratories
K830689	EMPTY DIALYSATE CONTAINER BB-69	Mar 29, 1983	Substantially Equivalent	Delmed, Inc.
K823827	AMP 80/2 OUTFLOW MONITOR MODIFICATION	Mar 17, 1983	Substantially Equivalent	American Medical Products, Inc.
K830208	BETA-CAP D ADAPTER	Mar 07, 1983	Substantially Equivalent	Quinton, Inc.
K830257	NON-STERILE PERITONEAL ACCESS CATHET-	Feb 24, 1983	Substantially Equivalent	Evermed, Inc.
K823857	IMPRA PERITONEAL CATHETER	Jan 26, 1983	Substantially Equivalent	Impra, Inc.
K823390	PC 201A LOCKING SLEEVE	Jan 26, 1983	Substantially Equivalent	Medigroup
K823331	PC-204 TUNNELOR	Jan 26, 1983	Substantially Equivalent	Medigroup
K823330	DIALATORS PC-203 & 202	Jan 26, 1983	Substantially Equivalent	Medigroup
K823303	QUILL CATHETER GUIDE	Jan 26, 1983	Substantially Equivalent	Medigroup
K823296	PC-205 TENCKHOFF CATHETER ROD OBTURATOR	Jan 26, 1983	Substantially Equivalent	Medigroup
K823777	STERILE, DISPOS. SPIKE PROTECTOR-5C4138	Jan 07, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K823217	INPERSOL PERITONEAL DIALSIS CYCLER SET	Nov 30, 1982	Substantially Equivalent	Abbott Laboratories
K822712	INPERSOL-CAPD ADMINIS. SET TYPE DP	Oct 21, 1982	Substantially Equivalent	Abbott Laboratories
K822658	EXTENSION SET TYPE DP	Oct 21, 1982	Substantially Equivalent	Abbott Laboratories
K822550	SAFE LOCK TITANIUM ADAPTER SET	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822549	CCPD CYCLER SET W/5 PRONGED SAFE LOCK	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822548	SAFE LOCK CATHETER S-3	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822546	SAFE LOCK SEALING CAPS	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822545	CCPD CYCLER SET W/5 PRONGED CONNECTOR	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822544	SAFE LOCK SEALING CAP L	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822543	CAPD SAFE LOCK TRANSFER SET	Oct 13, 1982	Substantially Equivalent	American Medical Products, Inc.
K822547	CAPD BELT	Sep 09, 1982	Substantially Equivalent	American Medical Products, Inc.
K822025	AUTOMATIC SPLICING DEVICE	Sep 09, 1982	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K822361	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	Aug 16, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K820179	ERIKA CAPD PREP KIT #30-9501-5	Feb 19, 1982	Substantially Equivalent	Erika, Inc.
K813487	CATHETER BUBBLE STAND	Dec 31, 1981	Substantially Equivalent	Accurate Surgical Instruments Co.
K811986	THE AMP 80/2 PEDIATRIC CYCLER SYSTEM	Aug 31, 1981	Substantially Equivalent	American Medical Products, Inc.
K810683	CAPD CATHETER ADAPTER	May 08, 1981	Substantially Equivalent	American Mcgaw
K791342	ADR-10600(ADR 400),10601 (ADR 300)	Nov 16, 1979	Substantially Equivalent	Physio-Control Corp.
K772150	DIALYSIS DRAINAGE UNIT, PERITONEAL	Nov 28, 1977	Substantially Equivalent	C.R. Bard, Inc.
K771484	RINSE BLOCK ASSEM, D-W PERI. DIALYSIS	Oct 25, 1977	Substantially Equivalent	Quinton, Inc.