[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FIH":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":111,"syncDates":320},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},1173,"FIH","Pump, Infusion Or Syringe, Extra-Luminal","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":18,"fei_number":24,"registration_number":27},[19,20,21,22,23],"K900439","K935461","K931113","K932055","K881707",[25,26],"3004753774","3012044688",[25,26],"N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,139,[],[39,47,54,62,69,76,83,90,97,104],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},449,"注射筒輸液ポンプ","Ⅲ","13217000",0.564103,0.750465,0.0327869,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":53},450,"オキシトシン注射筒輸液ポンプ","16167000",0.489362,0.737103,0.032002,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":33,"vector_similarity":60,"score":61},2195,"非静注インフュージョンポンプ","Ⅱ","70394000",0.294118,0.743288,0.0304147,{"medical_device_id":63,"generic_name":64,"class_classification":42,"jmdn_code":65,"name_similarity":66,"definition_similarity":33,"vector_similarity":67,"score":68},447,"経腸栄養用輸液ポンプ","13209000",0.326923,0.719668,0.0300769,{"medical_device_id":70,"generic_name":71,"class_classification":57,"jmdn_code":72,"name_similarity":73,"definition_similarity":33,"vector_similarity":74,"score":75},2129,"輸液ポンプ用延長チューブ","12170052",0.354167,0.716066,0.0298774,{"medical_device_id":77,"generic_name":78,"class_classification":42,"jmdn_code":79,"name_similarity":80,"definition_similarity":33,"vector_similarity":81,"score":82},456,"注射筒輸液ポンプコントロールユニット","37217000",0.423077,0.700238,0.0295716,{"medical_device_id":84,"generic_name":85,"class_classification":42,"jmdn_code":86,"name_similarity":87,"definition_similarity":33,"vector_similarity":88,"score":89},448,"汎用輸液ポンプ","13215000",0.288462,0.733104,0.0295139,{"medical_device_id":91,"generic_name":92,"class_classification":57,"jmdn_code":93,"name_similarity":94,"definition_similarity":33,"vector_similarity":95,"score":96},1414,"インフュージョンポンプ","70058000",0.358974,0.699331,0.0291385,{"medical_device_id":98,"generic_name":99,"class_classification":42,"jmdn_code":100,"name_similarity":101,"definition_similarity":33,"vector_similarity":102,"score":103},451,"マルチチャンネル輸液ポンプ","17634000",0.269231,0.718078,0.0282194,{"medical_device_id":105,"generic_name":106,"class_classification":42,"jmdn_code":107,"name_similarity":108,"definition_similarity":33,"vector_similarity":109,"score":110},452,"加温ハイフロー輸液ポンプ","17907010",0.290909,0.702031,0.028169,[112,116,120,124,128,132,136,140,144,148,152,155,159,163,166,170,173,177,180,184,187,190,193,196,199,202,206,209,212,215,218,221,225,228,231,234,237,241,244,248,251,254,257,260,263,266,269,272,275,278,281,284,287,290,293,296,299,302,305,308,311,314,317],{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"LIF","Dialyzer Reprocessing System",57,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"FJG","Dialyzer, Parallel Flow",36,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FIB","Protector, Transducer, Dialysis",35,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"FIN","Tank, Holding, Dialysis",18,{"product_code":153,"device_name":154,"device_class":8,"k510_count":151},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"FHS","Dialyzer, Single Coil",12,{"product_code":164,"device_name":165,"device_class":8,"k510_count":162},"FKR","Subsystem, Proportioning",{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":171,"device_name":172,"device_class":8,"k510_count":169},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":178,"device_name":179,"device_class":8,"k510_count":176},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":181,"device_name":182,"device_class":8,"k510_count":183},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":185,"device_name":186,"device_class":12,"k510_count":183},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":188,"device_name":189,"device_class":8,"k510_count":183},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":191,"device_name":192,"device_class":8,"k510_count":183},"MNV","Strip, Dialysate Ph Indicator",{"product_code":194,"device_name":195,"device_class":8,"k510_count":35},"FJF","Detector, Air Bubble",{"product_code":197,"device_name":198,"device_class":8,"k510_count":35},"FJT","Intracatheter, Dialysis",{"product_code":200,"device_name":201,"device_class":8,"k510_count":35},"FKJ","Filter, Blood, Dialysis",{"product_code":203,"device_name":204,"device_class":8,"k510_count":205},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":207,"device_name":208,"device_class":8,"k510_count":205},"FJD","Detector, Leak, Blood",{"product_code":210,"device_name":211,"device_class":8,"k510_count":205},"FKY","Connector, Tubing, Dialysate",{"product_code":213,"device_name":214,"device_class":8,"k510_count":205},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":216,"device_name":217,"device_class":8,"k510_count":205},"KXM","System Accessories, Extracorporeal",{"product_code":219,"device_name":220,"device_class":8,"k510_count":205},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"FID","Tubing, Dialysate",3,{"product_code":226,"device_name":227,"device_class":8,"k510_count":224},"FJB","Detector, Dialysate Level",{"product_code":229,"device_name":230,"device_class":8,"k510_count":224},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":232,"device_name":233,"device_class":8,"k510_count":224},"FKI","Set, Dialyzer Holder",{"product_code":235,"device_name":236,"device_class":8,"k510_count":224},"FLA","Monitor, Temperature, Dialysis",{"product_code":238,"device_name":239,"device_class":8,"k510_count":240},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":242,"device_name":243,"device_class":8,"k510_count":240},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":245,"device_name":246,"device_class":8,"k510_count":247},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":249,"device_name":250,"device_class":8,"k510_count":247},"FIW","Alarm, Pillow Pressure",{"product_code":252,"device_name":253,"device_class":8,"k510_count":247},"FJC","Detector, Blood Level",{"product_code":255,"device_name":256,"device_class":8,"k510_count":247},"FKD","Canister, Coil",{"product_code":258,"device_name":259,"device_class":8,"k510_count":247},"FKL","Insert, Pump, Blood",{"product_code":261,"device_name":262,"device_class":8,"k510_count":247},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":264,"device_name":265,"device_class":8,"k510_count":247},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":267,"device_name":268,"device_class":8,"k510_count":247},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":270,"device_name":271,"device_class":12,"k510_count":33},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":273,"device_name":274,"device_class":8,"k510_count":33},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":276,"device_name":277,"device_class":8,"k510_count":33},"FIS","Flowmeter, Dialysate",{"product_code":279,"device_name":280,"device_class":8,"k510_count":33},"FJA","Manometer, Water",{"product_code":282,"device_name":283,"device_class":8,"k510_count":33},"FJJ","Dialyzer, Twin Coil",{"product_code":285,"device_name":286,"device_class":8,"k510_count":33},"FJP","Adaptor, Y",{"product_code":288,"device_name":289,"device_class":12,"k510_count":33},"FKE","Tie, Dialysis",{"product_code":291,"device_name":292,"device_class":12,"k510_count":33},"FKF","Gun, Tie, Dialysis",{"product_code":294,"device_name":295,"device_class":8,"k510_count":33},"FKM","Adaptor, Fistula",{"product_code":297,"device_name":298,"device_class":8,"k510_count":33},"KQR","Detector, Air Or Foam",{"product_code":300,"device_name":301,"device_class":12,"k510_count":33},"MON","System, Hemodialysis, Remote Accessories",{"product_code":303,"device_name":304,"device_class":8,"k510_count":33},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":306,"device_name":307,"device_class":8,"k510_count":33},"PEV","Dialysis Administration Kit",{"product_code":309,"device_name":310,"device_class":8,"k510_count":33},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":312,"device_name":313,"device_class":8,"k510_count":33},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":315,"device_name":316,"device_class":8,"k510_count":33},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":318,"device_name":319,"device_class":8,"k510_count":33},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":321,"classification":322,"enforcement":323,"event":324,"pma":325,"warning_letter":326},"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"]