System, Peritoneal, Automatic Delivery
FDA product code FKX · Class II (moderate risk) · 21 CFR 876.5630 · Gastroenterology, Urology
83510(k) clearances
0PMA approvals
42recalls
Manufacturers
- American Medical Products, Inc. 11
- Travenol Laboratories, S.A. 8
- Baxter Healthcare Corp 7
- Fresenius Medical Care Renal Therapies Group, LLC 6
- Abbott Laboratories 6
- Medionics International , Ltd. 5
- Medigroup 5
- Quinton, Inc. 4
- Delmed, Inc. 3
- Fresenius Medical Care North America 2
- Deka Research & Development Corp. 2
- E.I. Dupont DE Nemours & Co., Inc. 2
- American Mcgaw 2
- Impra, Inc. 1
- Evermed, Inc. 1
- Erika, Inc. 1
- Simergent, LLC 1
- Accurate Surgical Instruments Co. 1
- Organon Teknika Corp. 1
- Physio-Control Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional | Simergent, LLC | 10/02/2025SE |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional | Byonyks Pvt, Ltd. | 05/16/2025SE |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional | Iren-Medical, Ltd. | 12/29/2022SE |
| K222318 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/31/2022SE |
| K212522 | Lilliput APD SystemFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2022SE |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional | Cloudcath | 02/09/2022SE |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional | Baxter Healthcare Corporation | 11/19/2020SE |
| K181108 | Fresenius Liberty Select CyclerFKX · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/24/2018SE |
| K173718 | Liberty Cycler SetFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/01/2018SE |
| K171652 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/15/2017SE |
| K151525 | Amia Automated PD System with SharesourceFKX · Traditional | Deka Research and Development | 10/09/2015SE |
| K141145 | Liberty PDX CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/30/2014SE |
| K123630 | Fresenius Liberty CyclerFKX · Traditional | Fresenius Medical Care North America, Design Cente | 09/09/2013SE |
| K124018 | Amia Automated PD SystemFKX · Traditional | Deka Research & Development Corp. | 06/14/2013SE |
| K103220 | Voyager Peritoneal Dialysis SystemFKX · Traditional | Deka Research & Development Corp. | 07/29/2011SE |
| K102936 | Homechoice/Homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model…FKX · Traditional | Baxter Healthcare Corp | 03/30/2011SE |
| K053512 | Homechoice/Homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and…FKX · Traditional | Baxter Healthcare Corp | 02/16/2006SE |
| K043363 | Fresenius Liberty CyclerFKX · Traditional | Fresenius Medical Care North America | 03/31/2005SE |
| K012988 | Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471…FKX · Traditional | Baxter Healthcare Corp | 12/05/2001SE |
| K002892 | Frsenius PD Iqcard CyclerFKX · Traditional | Fresenius Medical Care North America | 04/05/2001SE |
| K994218 | Easy Care and Tubing SetsFKX · Special | Medionics International, Inc. | 02/10/2000SE |
| K935659 | Baxter Night Exch Device(Nxd) Peritoneal Dialy SystFKX · Traditional | Baxter Healthcare Corp | 07/07/1994SE |
| K923065 | Baxter Personal Cycler Autommated Peritoneal DialFKX · Traditional | Baxter Healthcare Corp | 03/04/1994SE |
| K933687 | R & D Batteries,Inc. Part Numbers 5164, 5272, 5260FKX · Traditional | R & D Batteries, Inc. | 02/09/1994SE |
| K905809 | NMC Cycler MachineFKX · Traditional | National Medical Care, Medical Products Div., Inc. | 02/25/1992SE |
| K910173 | Selectra and Tubing SetsFKX · Traditional | Medionics International , Ltd. | 01/13/1992SE |
| K902149 | Fresenius/Delmed 90/2 Peritoneal Dialysis SystemFKX · Traditional | Fresenius/Delmed, Inc. | 10/30/1990SE |
| K901478 | Delmed 80/2 Dialysis System W/Last Bag OptionFKX · Traditional | Delmed, Inc. | 07/27/1990SE |
| K901477 | Delmed 80/2 Dialysis System W/UltrafiltrationFKX · Traditional | Delmed, Inc. | 07/27/1990SE |
| K901228 | Multi-StripFKX · Traditional | Bellhouse Medical, Inc. | 05/07/1990SE |
| K895336 | Abbott Inpersol Cycler 1000FKX · Traditional | Abbott Laboratories | 11/28/1989SE |
| K884554 | Peritoneal Catheter Stabilization Device 5C4381FKX · Traditional | Baxter Healthcare Corp | 01/31/1989SE |
| K874632 | Bent Neck Curlcath Peritoneal Dialysis KitFKX · Traditional | Quinton, Inc. | 12/29/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | Travenol Laboratories, S.A. | 09/30/1987SE |
| K862928 | AMUKIN-50% for Capd Y-SetFKX · Traditional | Amuchina Intl., Inc. | 03/09/1987SE |
| K845042 | Abbott Inpersol Cycler 1000FKX · Traditional | Abbott Laboratories | 03/19/1985SE |
| K844630 | Rope System Reverse Osmosis Peritoneal SystemFKX · Traditional | Organon Teknika Corp. | 03/12/1985SE |
| K850406 | Automatic Peritoneal Dialysis Cycler SystemFKX · Traditional | Travenol Laboratories, S.A. | 02/21/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | Renal Systems, Inc. | 01/07/1985SE |
| K844144 | SCD Sterile Connection DeviceFKX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/16/1984SE |
| K842885 | Extended Life Capd Solution TransferFKX · Traditional | Travenol Laboratories, S.A. | 10/18/1984SE |
| K841929 | Lifemed Lifecoil CathetersFKX · Traditional | Lifemed of California | 08/08/1984SE |
| K842305 | C.A.P.D. Automatic Heater PDH 200FKX · Traditional | Medionics International , Ltd. | 06/25/1984SE |
| K840224 | Extended Life Capd Solution TransferFKX · Traditional | Travenol Laboratories, S.A. | 02/21/1984SE |
| K833749 | Peritoneal Catheter-Changes-FKX · Traditional | Quinton, Inc. | 12/27/1983SE |
| K833595 | Capd Ultraviolet Germicidal ExchangeFKX · Traditional | Travenol Laboratories, S.A. | 11/29/1983SE |
| K833065 | Automatic Peritoneal Dialysis CyclerFKX · Traditional | Travenol Laboratories, S.A. | 11/28/1983SE |
| K832141 | Microstar VC1 Volumetric CyclerFKX · Traditional | Medionics International , Ltd. | 10/14/1983SE |
| K831766 | Microstar VciFKX · Traditional | Medionics International , Ltd. | 10/14/1983SE |
| K831716 | Capd - Catheter AdapterFKX · Traditional | American Mcgaw | 06/24/1983SE |
| K830881 | Ampercide Disinfectant Accessory to -FKX · Traditional | American Medical Products, Inc. | 06/02/1983SE |
| K830766 | Abbott Patient Assist DeviceFKX · Traditional | Abbott Laboratories | 03/29/1983SE |
| K830689 | Empty Dialysate Container BB-69FKX · Traditional | Delmed, Inc. | 03/29/1983SE |
| K823827 | Amp 80/2 Outflow Monitor ModificationFKX · Traditional | American Medical Products, Inc. | 03/17/1983SE |
| K830208 | Beta-Cap D AdapterFKX · Traditional | Quinton, Inc. | 03/07/1983SE |
| K830257 | Non-Sterile Peritoneal Access Cathet-FKX · Traditional | Evermed, Inc. | 02/24/1983SE |
| K823857 | Impra Peritoneal CatheterFKX · Traditional | Impra, Inc. | 01/26/1983SE |
| K823390 | PC 201A Locking SleeveFKX · Traditional | Medigroup | 01/26/1983SE |
| K823331 | PC-204 TunnelorFKX · Traditional | Medigroup | 01/26/1983SE |
| K823330 | Dialators PC-203 & 202FKX · Traditional | Medigroup | 01/26/1983SE |
| K823303 | Quill Catheter GuideFKX · Traditional | Medigroup | 01/26/1983SE |
| K823296 | PC-205 Tenckhoff Catheter Rod ObturatorFKX · Traditional | Medigroup | 01/26/1983SE |
| K823777 | Sterile, Dispos. Spike PROTECTOR-5C4138FKX · Traditional | Travenol Laboratories, S.A. | 01/07/1983SE |
| K823217 | Inpersol Peritoneal Dialsis Cycler SetFKX · Traditional | Abbott Laboratories | 11/30/1982SE |
| K822712 | Inpersol-Capd Adminis. Set Type DPFKX · Traditional | Abbott Laboratories | 10/21/1982SE |
| K822658 | Extension Set Type DPFKX · Traditional | Abbott Laboratories | 10/21/1982SE |
| K822550 | Safe Lock Titanium Adapter SetFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822549 | CCPD Cycler Set W/5 Pronged Safe LockFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822548 | Safe Lock Catheter S-3FKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822546 | Safe Lock Sealing CapsFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822545 | CCPD Cycler Set W/5 Pronged ConnectorFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822544 | Safe Lock Sealing Cap LFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822543 | Capd Safe Lock Transfer SetFKX · Traditional | American Medical Products, Inc. | 10/13/1982SE |
| K822547 | Capd BeltFKX · Traditional | American Medical Products, Inc. | 09/09/1982SE |
| K822025 | Automatic Splicing DeviceFKX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/09/1982SE |
| K822361 | Dianeal Solution Exchange Device #5C4193FKX · Traditional | Travenol Laboratories, S.A. | 08/16/1982SE |
| K820179 | Erika Capd Prep Kit #30-9501-5FKX · Traditional | Erika, Inc. | 02/19/1982SE |
| K813487 | Catheter Bubble StandFKX · Traditional | Accurate Surgical Instruments Co. | 12/31/1981SE |
| K811986 | The Amp 80/2 Pediatric Cycler SystemFKX · Traditional | American Medical Products, Inc. | 08/31/1981SE |
| K810683 | Capd Catheter AdapterFKX · Traditional | American Mcgaw | 05/08/1981SE |
| K791342 | ADR-10600(ADR 400),10601 (Adr 300)FKX · Traditional | Physio-Control Corp. | 11/16/1979SE |
| K772150 | Dialysis Drainage Unit, PeritonealFKX · Traditional | C.R. Bard, Inc. | 11/28/1977SE |
| K771484 | Rinse Block Assem, D-W Peri. DialysisFKX · Traditional | Quinton, Inc. | 10/25/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0409-2026 Class II | Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01…Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s… | Vantive US Healthcare LLC | 08/28/2025Open, Classified |
| Z-0550-2024 Class II | Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on… | Baxter Healthcare Corporation | 11/15/2023Open, Classified |
| Z-0619-2024 Class III | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the… | Fresenius Medical Care Holdings, Inc. | 10/24/2023Open, Classified |
| Z-1316-2023 Class II | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution…The electrical safety testing was not properly performed on the impacted devices and additional testing is… | Baxter Healthcare Corporation | 02/22/2023Open, Classified |
| Z-1144-2022 Class II | Effluent Sample BagCertain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within… | Baxter Healthcare Corporation | 04/21/2022Terminated |
| Z-2174-2021 Class II | Kaguya Automated Peritoneal Dialysis SystemBaxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA… | Baxter Healthcare Corporation | 06/30/2021Terminated |
| Z-2173-2021 Class II | Sharesource Connectivity Platform for Use with the Amia Automated PD SystemBaxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA… | Baxter Healthcare Corporation | 06/30/2021Terminated |
| Z-2085-2021 Class II | 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage…Exposed to freezing temperatures due to refrigerated truck malfunctions | Fresenius Medical Care Holdings, Inc. | 04/28/2021Terminated |
| Z-0439-2021 Class II | Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm… | Fresenius Medical Care Holdings, Inc. | 09/12/2020Completed |
| Z-2151-2019 Class II | Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform…Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A… | Fresenius Medical Care Renal Therapies… | 05/29/2019Terminated |
| Z-0850-2019 Class II | Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic…Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a… | Baxter Healthcare Corporation | 12/11/2018Terminated |
| Z-0849-2019 Class II | AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic…Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a… | Baxter Healthcare Corporation | 12/11/2018Terminated |
| Z-0030-2020 Class II | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path.…Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the… | Baxter Healthcare Corporation | 10/10/2018Terminated |
| Z-2597-2018 Class II | power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD…There were instances where the power cord socket detached from the back of the AMIA cycler when the power… | Baxter Healthcare Corporation | 07/12/2018Terminated |
| Z-1365-2018 Class II | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device…The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in… | Fresenius Medical Care Renal Therapies… | 01/24/2018Terminated |
| Z-3133-2017 Class II | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow… | Baxter Healthcare Corp | 09/01/2017Terminated |
| Z-3041-2017 Class II | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The…Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the… | Baxter Healthcare Corporation | 07/05/2017Terminated |
| Z-3040-2017 Class II | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The…Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the… | Baxter Healthcare Corporation | 07/05/2017Terminated |
| Z-1056-2017 Class II | APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment…Customer complaints received for the presence of leaks | Baxter Healthcare Corporation | 12/16/2016Terminated |
| Z-1565-2016 Class II | Automated peritoneal dialysis (APD) cyclerBaxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the… | Baxter Healthcare Corp. | 02/16/2016Terminated |
| Z-0693-2016 Class II | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111The door latch may not fully close and the door may open unexpectedly. The door may make physical contact… | Fresenius Medical Care Renal Therapies… | 12/15/2015Terminated |
| Z-0291-2016 Class III | Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated…Loud operating sounds, which was unacceptable to the end users when the device was powered on. The… | Baxter Healthcare Corp. | 06/29/2015Terminated |
| Z-1039-2015 Class II | Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path.…Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong… | Baxter Healthcare Corp. | 12/08/2014Terminated |
| Z-1031-2015 Class II | HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis.…The keypad buttons on HomeChoice devices may be activated without the operator pressing them. | Baxter Healthcare Corp. | 10/21/2014Terminated |
| Z-0939-2015 Class II | HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's…There are additional and updated warning and cautions that are not in the Patient At-Home Guide for… | Baxter Healthcare Corp. | 10/06/2014Terminated |
| Z-0932-2015 Class II | Baxter Amia Automated PD systems are used in the treatment of adult renal failure…System error 01779 is produced when the battery cannot be charged due to specific voltage differences… | Baxter Healthcare Corp. | 04/24/2014Terminated |
| Z-1292-2015 Class II | The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro…The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects… | Baxter Healthcare Corp. | 10/16/2013Terminated |
| Z-0148-2014 Class II | Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a…Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate… | Fresenius Medical Care Holdings, Inc. | 10/14/2013Terminated |
| Z-2609-2016 Class II | 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device…In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to… | Baxter Healthcare Corp. | 10/07/2013Terminated |
| Z-1674-2013 Class II | Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated…Cassette may leak during set up or during peritoneal dialysis treatment | Fresenius Medical Care Holdings, Inc. | 06/03/2013Terminated |
| Z-0799-2013 Class II | Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and…There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become… | Fresenius Medical Care Holdings, Inc. | 10/12/2012Terminated |
| Z-2132-2012 Class II | Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container…Baxter discovered that a Baxter technical service representative was providing incorrect instructions for… | Baxter Healthcare Renal Div | 07/06/2012Terminated |
| Z-1448-2012 | Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic…Increased risk of intraperitoneal volume (IIPV), referred to as Overfill | Fresenius Medical Care Holdings, Inc. | 03/30/2012Terminated |
| Z-2747-2011 | Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to…A change made in the Quinton BETA-CAP adapter used to connect the patient PD catheter to the Baxter transfer… | Baxter Healthcare Renal Div | 05/19/2011Terminated |
| Z-2129-2011 | APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO…Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide… | Baxter Healthcare Renal Div | 03/16/2011Terminated |
| Z-0105-2011 | LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… | Fresenius Medical Care Holdings, Inc. | 09/03/2010Terminated |
| Z-0104-2011 | LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… | Fresenius Medical Care Holdings, Inc. | 09/03/2010Terminated |
| Z-0103-2011 | LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… | Fresenius Medical Care Holdings, Inc. | 09/03/2010Terminated |
| Z-0800-2010 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R…Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV).… | Baxter Healthcare Renal Div | 01/08/2010Terminated |
| Z-0799-2010 | Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471…Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV).… | Baxter Healthcare Renal Div | 01/08/2010Terminated |
| Z-0947-2008 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R…Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the… | Baxter Healthcare Renal Div | 11/20/2007Terminated |
| Z-0946-2008 | Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471…Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the… | Baxter Healthcare Renal Div | 11/20/2007Terminated |