ClearanceBrief
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)
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Top companies in FKX

DateFirm and productCodeLinked 510(k)
Oct 29, 2025Vantive 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
FKXK201867
Dec 26, 2023Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Open, Classified
FKXK222318
Dec 14, 2023Baxter Healthcare Corporation
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
Open, Classified
FKXK151525
Apr 1, 2023Baxter Healthcare Corporation
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Open, Classified
FKXK201867
Apr 21, 2022Baxter Healthcare Corporation
Effluent Sample Bag
Terminated
FKXNone listed
Jun 30, 2021BAXTER HEALTHCARE CORPORATION
Kaguya Automated Peritoneal Dialysis System
Terminated
FKXK151525
Jun 30, 2021BAXTER HEALTHCARE CORPORATION
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Terminated
FKXK151525
Apr 28, 2021Fresenius 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
FKXK043363
Sep 12, 2020Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Completed
FKXK171652
May 29, 2019Fresenius 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
FKXK173718
Dec 11, 2018Baxter 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
FKXK151525
Dec 11, 2018Baxter 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
FKXK151525
Oct 10, 2018Baxter Healthcare Corporation
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Terminated
FKXK102936
Jul 12, 2018Baxter Healthcare Corporation
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
Terminated
FKXK151525
Jan 24, 2018Fresenius 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
FKXK171652
Sep 1, 2017Baxter Healthcare Corp
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Terminated
FKXK151525
Jul 5, 2017Baxter 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
FKXK102936
Jul 5, 2017Baxter 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
FKXK102936
Jan 19, 2017Baxter 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
FKXK102936
Feb 16, 2016Baxter Healthcare Corp.
Automated peritoneal dialysis (APD) cycler
Terminated
FKXK151525
Jan 27, 2016Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Terminated
FKXK043363
K123630
Nov 17, 2015Baxter Healthcare Corp.
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Terminated
FKXK102936
Mar 18, 2015Baxter 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
FKXK102936
Feb 2, 2015Baxter 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
FKXK102936
Jan 29, 2015Baxter Healthcare Corp.
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Terminated
FKXK102936
Jan 7, 2015Baxter Healthcare Corp.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Terminated
FKXK124018
Jan 7, 2015Baxter 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
FKXK102936
Nov 5, 2013Fresenius 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
FKXK043363
Oct 7, 2013Baxter 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
FKXK102936
Jul 10, 2013Fresenius 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
FKXK043363
Feb 11, 2013Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Terminated
FKXK043363
Aug 2, 2012Baxter 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
FKXK923065
Apr 24, 2012Fresenius 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
FKXK043363
Jul 6, 2011Baxter 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
FKXNone listed
May 3, 2011Baxter 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
FKXK053512
Oct 20, 2010Fresenius 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
FKXK043363
Oct 20, 2010Fresenius 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
FKXK043363
Oct 20, 2010Fresenius 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
FKXK043363
Mar 1, 2010Baxter 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
FKXK053512
Mar 1, 2010Baxter 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
FKXK053512
Mar 7, 2008Baxter 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
FKXK012988
Mar 7, 2008Baxter 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
FKXK923065
May 3, 2006Fresenius 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
FKXK002892
Nov 16, 2005Baxter 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
FKXK012988
Jul 19, 2005Baxter 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
FKXK012988
Jul 19, 2005Baxter 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
FKXK923065
Jan 15, 2005Baxter 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
FKXK012988
Nov 11, 2004Baxter 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
FKXK012988
Nov 11, 2004Baxter 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
FKXK012988
Jul 20, 2004Baxter 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
FKXK012988

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