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) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08964004471001 | X-1 APD Cycler | BYONYKS PRIVATE LIMITED | 2025-09-08 |
| 50085412030536 | NA | Baxter Healthcare SA | 2025-08-28 |
| 10840861102706 | Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2024-03-19 |
| 10840861102713 | Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2024-03-19 |
| 00840861102280 | VersiPD | Fresenius Usa, Inc. | 2023-08-01 |
| 00840861102198 | VersiPD | Fresenius Usa, Inc. | 2023-02-14 |
| 10840861102218 | VersiPD | Fresenius Medical Care Holdings, Inc. | 2023-02-14 |
| 10840861102225 | VersiPD | Fresenius Medical Care Holdings, Inc. | 2023-02-14 |
| 10840861102232 | VersiPD | Fresenius Medical Care Holdings, Inc. | 2023-02-14 |
| 00840861102297 | VersiPD | Fresenius Usa, Inc. | 2023-02-14 |
| 10840861102614 | VersiPD | Fresenius Medical Care Holdings, Inc. | 2023-02-14 |
| 00860006810238 | CloudCath Connect - Patient Monitoring Software | Gastroklenz Inc. | 2022-08-17 |
| 00860006810207 | CloudCath Drain Set - Baxter Configuration | Gastroklenz Inc. | 2022-08-12 |
| 00860006810269 | CloudCath Drain Set - Fresenius Configuration | Gastroklenz Inc. | 2022-08-12 |
| 00860006810214 | CloudCath Sensor (Sensing Hardware) | Gastroklenz Inc. | 2022-08-05 |
| 10884450462758 | Peritoneal Dialysis | Merit Medical Systems, Inc. | 2021-10-22 |
| 10884450462772 | Peritoneal Dialysis | Merit Medical Systems, Inc. | 2021-10-22 |
| 10884450462789 | Peritoneal Dialysis | Merit Medical Systems, Inc. | 2021-06-03 |
| 50085412676468 | Homechoice Claria | BAXTER HEALTHCARE CORPORATION | 2020-12-01 |
| 15413765545723 | Sharesource | BAXTER HEALTHCARE CORPORATION | 2020-12-01 |
| 25413765545720 | Sharesource | BAXTER HEALTHCARE CORPORATION | 2020-12-01 |
| 10884521004795 | Argyle | Covidien LP | 2015-10-24 |
| 10840861101112 | Liberty® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100627 | Liberty® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100658 | Safe-Lock® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100672 | Premier | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100689 | Premier | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 00840861100705 | Safe-Lock® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100733 | Liberty® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |
| 10840861100740 | Liberty® | Fresenius Medical Care Holdings, Inc. | 2015-10-02 |