FKX · Class II · 21 CFR 876.5630

FDA Product Code FKX: System, Peritoneal, Automatic Delivery

Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories 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 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 Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
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 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 Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Nov 16, 1984
SCD STERILE CONNECTION DEVICE
K844144
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 24d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658
Abbott Laboratories
Gastroenterology & Urology · 48d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Sep 09, 1982
AUTOMATIC SPLICING DEVICE
K822025
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 59d
Cleared Nov 28, 1977
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150
C.R. Bard, Inc.
Gastroenterology & Urology · 14d

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 →