FKX · Class II · 21 CFR 876.5630

FDA Product Code FKX: System, Peritoneal, Automatic Delivery

Leading manufacturers include Travenol Laboratories, S.A., Baxter Healthcare Corp and Fresenius Medical Care Renal Therapies Group, LLC.

83
Total
83
Cleared
106d
Avg days
1977
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 211d recently vs 103d historically

FDA 510(k) Cleared System, Peritoneal, Automatic Delivery Devices (Product Code FKX)

83 devices
1–24 of 83
Cleared Oct 02, 2025
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)
K250523
Simergent, LLC
Gastroenterology & Urology · 223d
Cleared May 16, 2025
Byonyks X-1 APD Cycler
K243371
Byonyks Pvt, Ltd.
Gastroenterology & Urology · 198d
Cleared Dec 29, 2022
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
K220935
Iren-Medical, Ltd.
Gastroenterology & Urology · 273d
Cleared Oct 31, 2022
Fresenius Liberty Select Cycler
K222318
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 90d
Cleared Apr 15, 2022
Lilliput APD System
K212522
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 247d
Cleared Feb 09, 2022
CloudCath Peritoneal Dialysis Drain Set Monitoring System
K212658
Cloudcath
Gastroenterology & Urology · 170d
Cleared Nov 19, 2020
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
K201867
Baxter Healthcare Corporation
Gastroenterology & Urology · 135d
Cleared May 24, 2018
Fresenius Liberty Select Cycler
K181108
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 27d
Cleared May 01, 2018
Liberty Cycler Set
K173718
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 147d
Cleared Sep 15, 2017
Fresenius Liberty Select Cycler
K171652
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 102d
Cleared Jul 30, 2014
LIBERTY PDX CYCLER
K141145
Fresenius Medical Care Renal Therapies Group, LLC
Gastroenterology & Urology · 89d
Cleared Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
K102936
Baxter Healthcare Corp
Gastroenterology & Urology · 177d
Cleared Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
K053512
Baxter Healthcare Corp
Gastroenterology & Urology · 62d
Cleared Mar 31, 2005
FRESENIUS LIBERTY CYCLER
K043363
Fresenius Medical Care North America
Gastroenterology & Urology · 114d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
K002892
Fresenius Medical Care North America
Gastroenterology & Urology · 202d
Cleared Jul 07, 1994
BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST
K935659
Baxter Healthcare Corp
Gastroenterology & Urology · 225d
Cleared Mar 04, 1994
BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
K923065
Baxter Healthcare Corp
Gastroenterology & Urology · 617d
Cleared Feb 09, 1994
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687
R & D Batteries, Inc.
Gastroenterology & Urology · 195d
Cleared Feb 25, 1992
NMC CYCLER MACHINE
K905809
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 425d
Cleared Nov 28, 1989
ABBOTT INPERSOL CYCLER 1000
K895336
Abbott Laboratories
Gastroenterology & Urology · 89d
Cleared Jan 31, 1989
PERITONEAL CATHETER STABILIZATION DEVICE 5C4381
K884554
Baxter Healthcare Corp
Gastroenterology & Urology · 92d
Cleared Dec 29, 1987
BENT NECK CURLCATH PERITONEAL DIALYSIS KIT
K874632
Quinton, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 30, 1987
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652
Travenol Laboratories, S.A.
Gastroenterology & Urology · 85d

About Product Code FKX - Regulatory Context

510(k) Submission Activity

83 total 510(k) submissions under product code FKX since 1977, with 83 receiving FDA clearance (average review time: 106 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - FKX Product Code

Recent submissions under FKX have taken an average of 211 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.

FKX devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →