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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2025 | K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cy Simergent, LLC | FKX |
| May 16, 2025 | K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 Byonyks Pvt, Ltd., PK | FKX |
| Dec 29, 2022 | K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App Iren-Medical, Ltd., IL | FKX |
| Oct 31, 2022 | K222318 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Apr 15, 2022 | K212522 | Lilliput APD System Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Feb 9, 2022 | K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System Cloudcath | FKX |
| Nov 19, 2020 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation | FKX |
| May 24, 2018 | K181108 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| May 1, 2018 | K173718 | Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Sep 15, 2017 | K171652 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Oct 9, 2015 | K151525 | Amia Automated PD System with Sharesource Deka Research and Development | FKX |
| Jul 30, 2014 | K141145 | LIBERTY PDX CYCLER Fresenius Medical Care Renal Therapies Group, LLC | FKX |
| Sep 9, 2013 | K123630 | FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America, Design Cente | FKX |
| Jun 14, 2013 | K124018 | AMIA AUTOMATED PD SYSTEM Deka Research & Development Corp. | FKX |
| Jul 29, 2011 | K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM Deka Research & Development Corp. | FKX |
| Mar 30, 2011 | K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp | FKX |
| Feb 16, 2006 | K053512 | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 Baxter Healthcare Corp | FKX |
| Mar 31, 2005 | K043363 | FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America | FKX |
| Dec 5, 2001 | K012988 | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 Baxter Healthcare Corp | FKX |
| Apr 5, 2001 | K002892 | FRSENIUS PD IQCARD CYCLER Fresenius Medical Care North America | FKX |
| Feb 10, 2000 | K994218 | EASY CARE AND TUBING SETS Medionics International, Inc., CA | FKX |
| Jul 7, 1994 | K935659 | BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST Baxter Healthcare Corp | FKX |
| Mar 4, 1994 | K923065 | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL Baxter Healthcare Corp | FKX |
| Feb 9, 1994 | K933687 | R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 R & D Batteries, Inc. | FKX |
| Feb 25, 1992 | K905809 | NMC CYCLER MACHINE National Medical Care, Medical Products Div., Inc. | FKX |
| Jan 13, 1992 | K910173 | SELECTRA AND TUBING SETS Medionics International , Ltd., CA | FKX |
| Oct 30, 1990 | K902149 | FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM Fresenius/Delmed, Inc. | FKX |
| Jul 27, 1990 | K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION Delmed, Inc. | FKX |
| Jul 27, 1990 | K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION Delmed, Inc. | FKX |
| May 7, 1990 | K901228 | MULTI-STRIP Bellhouse Medical, Inc. | FKX |
| Nov 28, 1989 | K895336 | ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories | FKX |
| Jan 31, 1989 | K884554 | PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 Baxter Healthcare Corp | FKX |
| Dec 29, 1987 | K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT Quinton, Inc. | FKX |
| Sep 30, 1987 | K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. | FKX |
| Mar 9, 1987 | K862928 | AMUKIN-50% FOR CAPD Y-SET Amuchina Intl., Inc. | FKX |
| Mar 19, 1985 | K845042 | ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories | FKX |
| Mar 12, 1985 | K844630 | ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM Organon Teknika Corp. | FKX |
| Feb 21, 1985 | K850406 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. | FKX |
| Jan 7, 1985 | K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM Renal Systems, Inc. | FKX |
| Nov 16, 1984 | K844144 | SCD STERILE CONNECTION DEVICE E.I. Dupont DE Nemours & Co., Inc. | FKX |
| Oct 18, 1984 | K842885 | EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. | FKX |
| Aug 8, 1984 | K841929 | LIFEMED LIFECOIL CATHETERS Lifemed of California | FKX |
| Jun 25, 1984 | K842305 | C.A.P.D. AUTOMATIC HEATER PDH 200 Medionics International , Ltd. | FKX |
| Feb 21, 1984 | K840224 | EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. | FKX |
| Dec 27, 1983 | K833749 | PERITONEAL CATHETER-CHANGES- Quinton, Inc. | FKX |
| Nov 29, 1983 | K833595 | CAPD ULTRAVIOLET GERMICIDAL EXCHANGE Travenol Laboratories, S.A. | FKX |
| Nov 28, 1983 | K833065 | AUTOMATIC PERITONEAL DIALYSIS CYCLER Travenol Laboratories, S.A. | FKX |
| Oct 14, 1983 | K832141 | MICROSTAR VC1 VOLUMETRIC CYCLER Medionics International , Ltd. | FKX |
| Oct 14, 1983 | K831766 | MICROSTAR VCI Medionics International , Ltd. | FKX |
| Jun 24, 1983 | K831716 | CAPD - CATHETER ADAPTER American Mcgaw | FKX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.