FKX

Death

501

Injury

6,720

Malfunction

18,508

Other

1

Total

25,730

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) Simergent, LLC · 2025-10-02
• K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 Byonyks Pvt, Ltd. · 2025-05-16
• K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App Iren-Medical, Ltd. · 2022-12-29
• K222318 — Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC · 2022-10-31
• K212522 — Lilliput APD System Fresenius Medical Care Renal Therapies Group, LLC · 2022-04-15
• K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System Cloudcath · 2022-02-09
• K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation · 2020-11-19
• K181108 — Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC · 2018-05-24
• K173718 — Liberty Cycler Set Fresenius Medical Care Renal Therapies Group, LLC · 2018-05-01
• K171652 — Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC · 2017-09-15
• K151525 — Amia Automated PD System with Sharesource Deka Research and Development · 2015-10-09
• K141145 — LIBERTY PDX CYCLER Fresenius Medical Care Renal Therapies Group, LLC · 2014-07-30
• K123630 — FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America, Design Cente · 2013-09-09
• K124018 — AMIA AUTOMATED PD SYSTEM Deka Research & Development Corp. · 2013-06-14
• K103220 — VOYAGER PERITONEAL DIALYSIS SYSTEM Deka Research & Development Corp. · 2011-07-29
• K102936 — HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp · 2011-03-30
• K053512 — HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 Baxter Healthcare Corp · 2006-02-16
• K043363 — FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America · 2005-03-31
• K012988 — HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 Baxter Healthcare Corp · 2001-12-05
• K002892 — FRSENIUS PD IQCARD CYCLER Fresenius Medical Care North America · 2001-04-05
• K994218 — EASY CARE AND TUBING SETS Medionics International, Inc. · 2000-02-10
• K935659 — BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST Baxter Healthcare Corp · 1994-07-07
• K923065 — BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL Baxter Healthcare Corp · 1994-03-04
• K933687 — R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 R & D Batteries, Inc. · 1994-02-09
• K905809 — NMC CYCLER MACHINE National Medical Care, Medical Products Div., Inc. · 1992-02-25
• K910173 — SELECTRA AND TUBING SETS Medionics International , Ltd. · 1992-01-13
• K902149 — FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM Fresenius/Delmed, Inc. · 1990-10-30
• K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION Delmed, Inc. · 1990-07-27
• K901478 — DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION Delmed, Inc. · 1990-07-27
• K901228 — MULTI-STRIP Bellhouse Medical, Inc. · 1990-05-07
• K895336 — ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories · 1989-11-28
• K884554 — PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 Baxter Healthcare Corp · 1989-01-31
• K874632 — BENT NECK CURLCATH PERITONEAL DIALYSIS KIT Quinton, Inc. · 1987-12-29
• K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. · 1987-09-30
• K862928 — AMUKIN-50% FOR CAPD Y-SET Amuchina Intl., Inc. · 1987-03-09
• K845042 — ABBOTT INPERSOL CYCLER 1000 Abbott Laboratories · 1985-03-19
• K844630 — ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM Organon Teknika Corp. · 1985-03-12
• K850406 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. · 1985-02-21
• K844108 — RENAL SYSTEMS PERITONEAL ACCESS SYSTEM Renal Systems, Inc. · 1985-01-07
• K844144 — SCD STERILE CONNECTION DEVICE E.I. Dupont DE Nemours & Co., Inc. · 1984-11-16
• K842885 — EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. · 1984-10-18
• K841929 — LIFEMED LIFECOIL CATHETERS Lifemed of California · 1984-08-08
• K842305 — C.A.P.D. AUTOMATIC HEATER PDH 200 Medionics International , Ltd. · 1984-06-25
• K840224 — EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. · 1984-02-21
• K833749 — PERITONEAL CATHETER-CHANGES- Quinton, Inc. · 1983-12-27
• K833595 — CAPD ULTRAVIOLET GERMICIDAL EXCHANGE Travenol Laboratories, S.A. · 1983-11-29
• K833065 — AUTOMATIC PERITONEAL DIALYSIS CYCLER Travenol Laboratories, S.A. · 1983-11-28
• K831766 — MICROSTAR VCI Medionics International , Ltd. · 1983-10-14
• K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER Medionics International , Ltd. · 1983-10-14
• K831716 — CAPD - CATHETER ADAPTER American Mcgaw · 1983-06-24
• K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - American Medical Products, Inc. · 1983-06-02
• K830689 — EMPTY DIALYSATE CONTAINER BB-69 Delmed, Inc. · 1983-03-29
• K830766 — ABBOTT PATIENT ASSIST DEVICE Abbott Laboratories · 1983-03-29
• K823827 — AMP 80/2 OUTFLOW MONITOR MODIFICATION American Medical Products, Inc. · 1983-03-17
• K830208 — BETA-CAP D ADAPTER Quinton, Inc. · 1983-03-07
• K830257 — NON-STERILE PERITONEAL ACCESS CATHET- Evermed, Inc. · 1983-02-24
• K823296 — PC-205 TENCKHOFF CATHETER ROD OBTURATOR Medigroup · 1983-01-26
• K823303 — QUILL CATHETER GUIDE Medigroup · 1983-01-26
• K823330 — DIALATORS PC-203 & 202 Medigroup · 1983-01-26
• K823331 — PC-204 TUNNELOR Medigroup · 1983-01-26
• K823390 — PC 201A LOCKING SLEEVE Medigroup · 1983-01-26
• K823857 — IMPRA PERITONEAL CATHETER Impra, Inc. · 1983-01-26
• K823777 — STERILE, DISPOS. SPIKE PROTECTOR-5C4138 Travenol Laboratories, S.A. · 1983-01-07
• K823217 — INPERSOL PERITONEAL DIALSIS CYCLER SET Abbott Laboratories · 1982-11-30
• K822658 — EXTENSION SET TYPE DP Abbott Laboratories · 1982-10-21
• K822712 — INPERSOL-CAPD ADMINIS. SET TYPE DP Abbott Laboratories · 1982-10-21
• K822543 — CAPD SAFE LOCK TRANSFER SET American Medical Products, Inc. · 1982-10-13
• K822544 — SAFE LOCK SEALING CAP L American Medical Products, Inc. · 1982-10-13
• K822545 — CCPD CYCLER SET W/5 PRONGED CONNECTOR American Medical Products, Inc. · 1982-10-13
• K822546 — SAFE LOCK SEALING CAPS American Medical Products, Inc. · 1982-10-13
• K822548 — SAFE LOCK CATHETER S-3 American Medical Products, Inc. · 1982-10-13
• K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK American Medical Products, Inc. · 1982-10-13
• K822550 — SAFE LOCK TITANIUM ADAPTER SET American Medical Products, Inc. · 1982-10-13
• K822025 — AUTOMATIC SPLICING DEVICE E.I. Dupont DE Nemours & Co., Inc. · 1982-09-09
• K822547 — CAPD BELT American Medical Products, Inc. · 1982-09-09
• K822361 — DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 Travenol Laboratories, S.A. · 1982-08-16
• K820179 — ERIKA CAPD PREP KIT #30-9501-5 Erika, Inc. · 1982-02-19
• K813487 — CATHETER BUBBLE STAND Accurate Surgical Instruments Co. · 1981-12-31
• K811986 — THE AMP 80/2 PEDIATRIC CYCLER SYSTEM American Medical Products, Inc. · 1981-08-31
• K810683 — CAPD CATHETER ADAPTER American Mcgaw · 1981-05-08
• K791342 — ADR-10600(ADR 400),10601 (ADR 300) Physio-Control Corp. · 1979-11-16
• K772150 — DIALYSIS DRAINAGE UNIT, PERITONEAL C.R. Bard, Inc. · 1977-11-28
• K771484 — RINSE BLOCK ASSEM, D-W PERI. DIALYSIS Quinton, Inc. · 1977-10-25