Panels › Gastroenterology, Urology › Product code FKX · Class 2
System, Peritoneal, Automatic Delivery
Regulation 876.5630
0510(k)s in 12 months (83 all time)
0recalls in 12 months (53 all time)
51recalls that name a 510(k)
Top companies in FKX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2025 | Vantive US Healthcare LLC Sharesource Connectivity Platform for Use with Homechoice Claria
Product Code 5CGM01
software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) Open, Classified |
FKX | K201867 |
| Dec 26, 2023 | Fresenius Medical Care Holdings, Inc. Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Open, Classified |
FKX | K222318 |
| Dec 14, 2023 | Baxter Healthcare Corporation Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 Open, Classified |
FKX | K151525 |
| Apr 1, 2023 | Baxter Healthcare Corporation Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. Open, Classified |
FKX | K201867 |
| Apr 21, 2022 | Baxter Healthcare Corporation Effluent Sample Bag Terminated |
FKX | None listed |
| Jun 30, 2021 | BAXTER HEALTHCARE CORPORATION Kaguya Automated Peritoneal Dialysis System Terminated |
FKX | K151525 |
| Jun 30, 2021 | BAXTER HEALTHCARE CORPORATION Sharesource Connectivity Platform for Use with the Amia Automated PD System Terminated |
FKX | K151525 |
| Apr 28, 2021 | Fresenius Medical Care Holdings, Inc. 026-20036A Liberty Drain Line, Luer Tap
For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting Terminated |
FKX | K043363 |
| Sep 12, 2020 | Fresenius Medical Care Holdings, Inc. Liberty Select Cycler
Software Version 2.9.0
Model Number 180343 and RTLR180343 Completed |
FKX | K171652 |
| May 29, 2019 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows:
(1) LIBERTY Line Cycler Set with Sta Terminated |
FKX | K173718 |
| Dec 11, 2018 | Baxter Healthcare Corporation Kaguya Automated Peritoneal Dialysis System
Product Usage:
It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal Terminated |
FKX | K151525 |
| Dec 11, 2018 | Baxter Healthcare Corporation AMIA Automated Peritoneal Dialysis System
Product Usage:
It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal d Terminated |
FKX | K151525 |
| Oct 10, 2018 | Baxter Healthcare Corporation L5C4531 X1
Integrated APD Set with Cassette 3-Prong
Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. Terminated |
FKX | K102936 |
| Jul 12, 2018 | Baxter Healthcare Corporation power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only) Terminated |
FKX | K151525 |
| Jan 24, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343
Product Usage:
The device is indicated for acute and chronic peritoneal dialysis. Terminated |
FKX | K171652 |
| Sep 1, 2017 | Baxter Healthcare Corp Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Terminated |
FKX | K151525 |
| Jul 5, 2017 | Baxter Healthcare Corporation HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R
Product Usage:
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the Terminated |
FKX | K102936 |
| Jul 5, 2017 | Baxter Healthcare Corporation HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R
Product Usage:
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the trea Terminated |
FKX | K102936 |
| Jan 19, 2017 | Baxter Healthcare Corporation APD Set with Cassette 3-Prong Peritoneal Dialysis Set
Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical an Terminated |
FKX | K102936 |
| Feb 16, 2016 | Baxter Healthcare Corp. Automated peritoneal dialysis (APD) cycler Terminated |
FKX | K151525 |
| Jan 27, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Liberty Cycler-Peritoneal Dialysis Cycler
Model: 180111 and RTLR180111 Terminated |
FKX | K043363 K123630 |
| Nov 17, 2015 | Baxter Healthcare Corp. Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Terminated |
FKX | K102936 |
| Mar 18, 2015 | Baxter Healthcare Corp. The HomeChoice Pro APD System is a peritoneal dialysis system.
The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange Terminated |
FKX | K102936 |
| Feb 2, 2015 | Baxter Healthcare Corp. Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path.
Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide P Terminated |
FKX | K102936 |
| Jan 29, 2015 | Baxter Healthcare Corp. HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474. Terminated |
FKX | K102936 |
| Jan 7, 2015 | Baxter Healthcare Corp. Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis. Terminated |
FKX | K124018 |
| Jan 7, 2015 | Baxter Healthcare Corp. HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's
HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediat Terminated |
FKX | K102936 |
| Nov 5, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler
Part Number: RTLR180111
Product Usage:
The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. Terminated |
FKX | K043363 |
| Oct 7, 2013 | Baxter Healthcare Corp. 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter.
2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on Terminated |
FKX | K102936 |
| Jul 10, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Set Single Conn./Ext DL
Product Number: 050-87216
Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. Terminated |
FKX | K043363 |
| Feb 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.
Acute and chronic peritoneal dialysis. Terminated |
FKX | K043363 |
| Aug 2, 2012 | Baxter Healthcare Renal Div Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter He Terminated |
FKX | K923065 |
| Apr 24, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8.
The Fresenius Liberty Cycler is intended for acute or Terminated |
FKX | K043363 |
| Jul 6, 2011 | Baxter Healthcare Renal Div Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560 Terminated |
FKX | None listed |
| May 3, 2011 | Baxter Healthcare Renal Div APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated |
FKX | K053512 |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA b Terminated |
FKX | K043363 |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoz Terminated |
FKX | K043363 |
| Oct 20, 2010 | Fresenius Medical Care Holdings, Inc. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Terminated |
FKX | K043363 |
| Mar 1, 2010 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R.
The HomeChoice dialysis system is a personal cycler automated perito Terminated |
FKX | K053512 |
| Mar 1, 2010 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR.
The HomeChoice dialysis system is a personal cycle Terminated |
FKX | K053512 |
| Mar 7, 2008 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | K012988 |
| Mar 7, 2008 | Baxter Healthcare Renal Div Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U Terminated |
FKX | K923065 |
| May 3, 2006 | Fresenius Medical Care North America Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis.
Catalog Number: 050-87028 Terminated |
FKX | K002892 |
| Nov 16, 2005 | Baxter Healthcare Renal Div Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A. Terminated |
FKX | K012988 |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5 Terminated |
FKX | K012988 |
| Jul 19, 2005 | Baxter Healthcare Renal Div HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, Terminated |
FKX | K923065 |
| Jan 15, 2005 | Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R Terminated |
FKX | K012988 |
| Nov 11, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300 Terminated |
FKX | K012988 |
| Nov 11, 2004 | Baxter Healthcare Renal Div HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441 Terminated |
FKX | K012988 |
| Jul 20, 2004 | Baxter Healthcare Renal Div HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, Terminated |
FKX | K012988 |
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