[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FKP":3},{"classification":4,"mappedDevices":85,"similarCandidates":86,"relatedClassifications":159,"syncDates":367},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":14,"raw":16,"created_at":78,"updated_at":79,"recall_count":80,"latest_recall_date":81,"k510_count":82,"pma_count":83,"event_count":84},5261,"FKP","System, Dialysate Delivery, Single Patient","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":75,"product_code":6,"review_panel":10,"gmp_exempt_flag":75,"third_party_flag":75,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":76,"medical_specialty_description":11,"summary_malfunction_reporting":77},{"k_number":18,"fei_number":69,"registration_number":73},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68],"K873155","K131739","K853513","K883111","K850179","K955423","K770350","K871218","K861230","K854367","K800425","K921456","K992255","K854479","K863609","K904967","K894838","K910215","K800330","K802250","K880459","K953854","K181991","K130460","K851306","K896757","K922757","K781405","K802880","K771696","K781886","K040074","K811972","K905388","K890824","K864083","K896758","K003615","K850569","K905793","K964264","K811591","K930181","K780682","K813432","K792173","K761287","K771065","K864094","K021060",[70,71,72],"2150060","1000140026","3029754060",[70,74,72],"2132111","N","Y","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",12,null,50,0,1065,[],[87,95,103,109,116,123,131,138,145,152],{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":83,"vector_similarity":93,"score":94},693,"多人数用透析液供給装置","Ⅲ","34993000",0.537037,0.717836,0.0327869,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":83,"vector_similarity":101,"score":102},2992,"患者適合型単回使用関節手術用器械","Ⅱ","70964212",0.285714,0.639354,0.0310096,{"medical_device_id":104,"generic_name":105,"class_classification":98,"jmdn_code":106,"name_similarity":100,"definition_similarity":83,"vector_similarity":107,"score":108},3000,"患者適合型単回使用骨手術用器械","70962212",0.621943,0.0305504,{"medical_device_id":110,"generic_name":111,"class_classification":98,"jmdn_code":112,"name_similarity":113,"definition_similarity":83,"vector_similarity":114,"score":115},2074,"単回使用透析用針","12741002",0.25,0.628352,0.0298774,{"medical_device_id":117,"generic_name":118,"class_classification":90,"jmdn_code":119,"name_similarity":120,"definition_similarity":83,"vector_similarity":121,"score":122},695,"多用途透析装置","34994020",0.236364,0.647001,0.0295716,{"medical_device_id":124,"generic_name":125,"class_classification":126,"jmdn_code":127,"name_similarity":128,"definition_similarity":83,"vector_similarity":129,"score":130},1182,"心臓用補綴材留置用デリバリーシステム","Ⅳ","45419004",0.253012,0.613338,0.0284045,{"medical_device_id":132,"generic_name":133,"class_classification":90,"jmdn_code":134,"name_similarity":135,"definition_similarity":83,"vector_similarity":136,"score":137},820,"自動腹膜灌流用装置","11226000",0.245902,0.616158,0.0279734,{"medical_device_id":139,"generic_name":140,"class_classification":90,"jmdn_code":141,"name_similarity":142,"definition_similarity":83,"vector_similarity":143,"score":144},691,"人工腎臓装置","34995000",0.229167,0.619403,0.0276506,{"medical_device_id":146,"generic_name":147,"class_classification":98,"jmdn_code":148,"name_similarity":149,"definition_similarity":83,"vector_similarity":150,"score":151},1492,"患者モニタシステム","37595000",0.326531,0.597791,0.027365,{"medical_device_id":153,"generic_name":154,"class_classification":90,"jmdn_code":155,"name_similarity":156,"definition_similarity":83,"vector_similarity":157,"score":158},1094,"単回使用陰圧創傷治療システム","58202003",0.222222,0.621886,0.0264706,[160,164,168,172,176,180,184,188,192,196,199,203,206,209,213,216,220,223,227,230,233,236,240,243,246,249,253,256,259,262,265,268,272,275,278,281,284,288,291,295,298,301,304,307,310,313,316,319,322,325,328,331,334,337,340,343,346,349,352,355,358,361,364],{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"LIF","Dialyzer Reprocessing System",57,{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"FJG","Dialyzer, Parallel Flow",36,{"product_code":189,"device_name":190,"device_class":8,"k510_count":191},"FIB","Protector, Transducer, Dialysis",35,{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"FIN","Tank, Holding, Dialysis",18,{"product_code":197,"device_name":198,"device_class":8,"k510_count":195},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":200,"device_name":201,"device_class":8,"k510_count":202},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":204,"device_name":205,"device_class":8,"k510_count":80},"FHS","Dialyzer, Single Coil",{"product_code":207,"device_name":208,"device_class":8,"k510_count":80},"FKR","Subsystem, Proportioning",{"product_code":210,"device_name":211,"device_class":8,"k510_count":212},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":214,"device_name":215,"device_class":8,"k510_count":212},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":221,"device_name":222,"device_class":8,"k510_count":219},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":224,"device_name":225,"device_class":8,"k510_count":226},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":228,"device_name":229,"device_class":12,"k510_count":226},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":231,"device_name":232,"device_class":8,"k510_count":226},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":234,"device_name":235,"device_class":8,"k510_count":226},"MNV","Strip, Dialysate Ph Indicator",{"product_code":237,"device_name":238,"device_class":8,"k510_count":239},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":241,"device_name":242,"device_class":8,"k510_count":239},"FJF","Detector, Air Bubble",{"product_code":244,"device_name":245,"device_class":8,"k510_count":239},"FJT","Intracatheter, Dialysis",{"product_code":247,"device_name":248,"device_class":8,"k510_count":239},"FKJ","Filter, Blood, Dialysis",{"product_code":250,"device_name":251,"device_class":8,"k510_count":252},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":254,"device_name":255,"device_class":8,"k510_count":252},"FJD","Detector, Leak, Blood",{"product_code":257,"device_name":258,"device_class":8,"k510_count":252},"FKY","Connector, Tubing, Dialysate",{"product_code":260,"device_name":261,"device_class":8,"k510_count":252},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":263,"device_name":264,"device_class":8,"k510_count":252},"KXM","System Accessories, Extracorporeal",{"product_code":266,"device_name":267,"device_class":8,"k510_count":252},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":269,"device_name":270,"device_class":8,"k510_count":271},"FID","Tubing, Dialysate",3,{"product_code":273,"device_name":274,"device_class":8,"k510_count":271},"FJB","Detector, Dialysate Level",{"product_code":276,"device_name":277,"device_class":8,"k510_count":271},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":279,"device_name":280,"device_class":8,"k510_count":271},"FKI","Set, Dialyzer Holder",{"product_code":282,"device_name":283,"device_class":8,"k510_count":271},"FLA","Monitor, Temperature, Dialysis",{"product_code":285,"device_name":286,"device_class":8,"k510_count":287},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":289,"device_name":290,"device_class":8,"k510_count":287},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":292,"device_name":293,"device_class":8,"k510_count":294},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":296,"device_name":297,"device_class":8,"k510_count":294},"FIW","Alarm, Pillow Pressure",{"product_code":299,"device_name":300,"device_class":8,"k510_count":294},"FJC","Detector, Blood Level",{"product_code":302,"device_name":303,"device_class":8,"k510_count":294},"FKD","Canister, Coil",{"product_code":305,"device_name":306,"device_class":8,"k510_count":294},"FKL","Insert, Pump, Blood",{"product_code":308,"device_name":309,"device_class":8,"k510_count":294},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":311,"device_name":312,"device_class":8,"k510_count":294},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":314,"device_name":315,"device_class":8,"k510_count":294},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":317,"device_name":318,"device_class":12,"k510_count":83},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":320,"device_name":321,"device_class":8,"k510_count":83},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":323,"device_name":324,"device_class":8,"k510_count":83},"FIS","Flowmeter, Dialysate",{"product_code":326,"device_name":327,"device_class":8,"k510_count":83},"FJA","Manometer, Water",{"product_code":329,"device_name":330,"device_class":8,"k510_count":83},"FJJ","Dialyzer, Twin Coil",{"product_code":332,"device_name":333,"device_class":8,"k510_count":83},"FJP","Adaptor, Y",{"product_code":335,"device_name":336,"device_class":12,"k510_count":83},"FKE","Tie, Dialysis",{"product_code":338,"device_name":339,"device_class":12,"k510_count":83},"FKF","Gun, Tie, Dialysis",{"product_code":341,"device_name":342,"device_class":8,"k510_count":83},"FKM","Adaptor, Fistula",{"product_code":344,"device_name":345,"device_class":8,"k510_count":83},"KQR","Detector, Air Or Foam",{"product_code":347,"device_name":348,"device_class":12,"k510_count":83},"MON","System, Hemodialysis, Remote Accessories",{"product_code":350,"device_name":351,"device_class":8,"k510_count":83},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":353,"device_name":354,"device_class":8,"k510_count":83},"PEV","Dialysis Administration Kit",{"product_code":356,"device_name":357,"device_class":8,"k510_count":83},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":359,"device_name":360,"device_class":8,"k510_count":83},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":362,"device_name":363,"device_class":8,"k510_count":83},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":365,"device_name":366,"device_class":8,"k510_count":83},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":368,"classification":369,"enforcement":370,"event":371,"pma":372,"warning_letter":373},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]