Product code FKX

Product
Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical De
Definition
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Description
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Regulation number
Radiation type
Radiation Emitting Electronic Product Codes // Qui
Applicable standards
Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Current FDA Classification

Device name
System, Peritoneal, Automatic Delivery
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.5630
Review panel
GU
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible

Related Records

Related 510(k) Records

510(k)DeviceApplicantDecision date
K250523Archimedes 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, LLC2025-10-02
K243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.2025-05-16
K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.2022-12-29
K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2022-10-31
K212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC2022-04-15
K212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath2022-02-09
K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation2020-11-19
K181108Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2018-05-24
K173718Liberty Cycler SetFresenius Medical Care Renal Therapies Group, LLC2018-05-01
K171652Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC2017-09-15
K151525Amia Automated PD System with SharesourceDeka Research and Development2015-10-09
K141145LIBERTY PDX CYCLERFresenius Medical Care Renal Therapies Group, LLC2014-07-30
K123630FRESENIUS LIBERTY CYCLERFresenius Medical Care North America, Design Cente2013-09-09
K124018AMIA AUTOMATED PD SYSTEMDeka Research & Development Corp.2013-06-14
K103220VOYAGER PERITONEAL DIALYSIS SYSTEMDeka Research & Development Corp.2011-07-29
K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RBaxter Healthcare Corp2011-03-30
K053512HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310Baxter Healthcare Corp2006-02-16
K043363FRESENIUS LIBERTY CYCLERFresenius Medical Care North America2005-03-31
K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469Baxter Healthcare Corp2001-12-05
K002892FRSENIUS PD IQCARD CYCLERFresenius Medical Care North America2001-04-05
K994218EASY CARE AND TUBING SETSMedionics International, Inc.2000-02-10
K935659BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYSTBaxter Healthcare Corp1994-07-07
K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALBaxter Healthcare Corp1994-03-04
K933687R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260R & D Batteries, Inc.1994-02-09
K905809NMC CYCLER MACHINENational Medical Care, Medical Products Div., Inc.1992-02-25
K910173SELECTRA AND TUBING SETSMedionics International , Ltd.1992-01-13
K902149FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEMFresenius/Delmed, Inc.1990-10-30
K901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONDelmed, Inc.1990-07-27
K901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONDelmed, Inc.1990-07-27
K901228MULTI-STRIPBellhouse Medical, Inc.1990-05-07

Related GUDID Devices

Primary DIBrandCompanyPublished
08964004471001X-1 APD CyclerBYONYKS PRIVATE LIMITED2025-09-08
50085412030536NABaxter Healthcare SA2025-08-28
10840861102706LibertyFresenius Medical Care Renal Therapies Group, LLC2024-03-19
10840861102713LibertyFresenius Medical Care Renal Therapies Group, LLC2024-03-19
00840861102280VersiPDFresenius Usa, Inc.2023-08-01
00840861102198VersiPDFresenius Usa, Inc.2023-02-14
10840861102218VersiPDFresenius Medical Care Holdings, Inc.2023-02-14
10840861102225VersiPDFresenius Medical Care Holdings, Inc.2023-02-14
10840861102232VersiPDFresenius Medical Care Holdings, Inc.2023-02-14
00840861102297VersiPDFresenius Usa, Inc.2023-02-14
10840861102614VersiPDFresenius Medical Care Holdings, Inc.2023-02-14
00860006810238CloudCath Connect - Patient Monitoring SoftwareGastroklenz Inc.2022-08-17
00860006810207CloudCath Drain Set - Baxter ConfigurationGastroklenz Inc.2022-08-12
00860006810269CloudCath Drain Set - Fresenius ConfigurationGastroklenz Inc.2022-08-12
00860006810214CloudCath Sensor (Sensing Hardware)Gastroklenz Inc.2022-08-05
10884450462758Peritoneal DialysisMerit Medical Systems, Inc.2021-10-22
10884450462772Peritoneal DialysisMerit Medical Systems, Inc.2021-10-22
10884450462789Peritoneal DialysisMerit Medical Systems, Inc.2021-06-03
50085412676468Homechoice ClariaBAXTER HEALTHCARE CORPORATION2020-12-01
15413765545723SharesourceBAXTER HEALTHCARE CORPORATION2020-12-01
25413765545720SharesourceBAXTER HEALTHCARE CORPORATION2020-12-01
10884521004795ArgyleCovidien LP2015-10-24
10840861101112Liberty®Fresenius Medical Care Holdings, Inc.2015-10-02
10840861100627Liberty®Fresenius Medical Care Holdings, Inc.2015-10-02
10840861100658Safe-Lock®Fresenius Medical Care Holdings, Inc.2015-10-02
10840861100672PremierFresenius Medical Care Holdings, Inc.2015-10-02
10840861100689PremierFresenius Medical Care Holdings, Inc.2015-10-02
00840861100705Safe-Lock®Fresenius Medical Care Holdings, Inc.2015-10-02
10840861100733Liberty®Fresenius Medical Care Holdings, Inc.2015-10-02
10840861100740Liberty®Fresenius Medical Care Holdings, Inc.2015-10-02