[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FLA":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":110,"syncDates":318,"translation":325,"marketSummary":331,"recalls":345,"k510s":347,"pmas":364},{"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},3084,"FLA","Monitor, Temperature, Dialysis","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":22,"registration_number":26},[19,20,21],"K842302","K810021","K140623",[23,24,25],"3014856521","3003464075","3002654698",[23,27,24],"9616074","N","Y","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:48.493322+00:00",0,null,3,1,[],[39,47,54,61,68,75,82,90,97,103],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},700,"透析装置用透析液温度モニタ","Ⅲ","32156000",0.674419,0.846087,0.0327869,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":53},692,"透析用監視装置","36424000",0.391304,0.817445,0.0322581,{"medical_device_id":55,"generic_name":56,"class_classification":42,"jmdn_code":57,"name_similarity":58,"definition_similarity":33,"vector_similarity":59,"score":60},695,"多用途透析装置","34994020",0.234043,0.70888,0.0281914,{"medical_device_id":62,"generic_name":63,"class_classification":42,"jmdn_code":64,"name_similarity":65,"definition_similarity":33,"vector_similarity":66,"score":67},697,"透析装置用透析液量検知器","32126000",0.218182,0.708473,0.0261905,{"medical_device_id":69,"generic_name":70,"class_classification":42,"jmdn_code":71,"name_similarity":72,"definition_similarity":33,"vector_similarity":73,"score":74},698,"透析装置用血液量検知器","32127000",0.214286,0.709995,0.0260695,{"medical_device_id":76,"generic_name":77,"class_classification":42,"jmdn_code":78,"name_similarity":79,"definition_similarity":33,"vector_similarity":80,"score":81},696,"透析装置用透析液流量計","32123000",0.215686,0.702942,0.0253831,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":33,"vector_similarity":88,"score":89},2263,"透析開始・終了セット","Ⅱ","32142000",0.219512,0.68784,0.0247064,{"medical_device_id":91,"generic_name":92,"class_classification":42,"jmdn_code":93,"name_similarity":94,"definition_similarity":33,"vector_similarity":95,"score":96},722,"人工心肺用温度コントロールユニット","36374000",0.220339,0.674308,0.0242433,{"medical_device_id":98,"generic_name":99,"class_classification":42,"jmdn_code":100,"name_similarity":65,"definition_similarity":33,"vector_similarity":101,"score":102},699,"透析装置用血液漏出検知器","32128000",0.683012,0.0241104,{"medical_device_id":104,"generic_name":105,"class_classification":85,"jmdn_code":106,"name_similarity":107,"definition_similarity":33,"vector_similarity":108,"score":109},1493,"セントラルモニタ","38470002",0.216216,0.670265,0.0231222,[111,115,119,123,127,131,135,139,143,147,151,154,158,162,165,169,172,176,179,183,186,189,192,196,199,202,205,209,212,215,218,221,224,227,230,233,236,240,243,246,249,252,255,258,261,264,267,270,273,276,279,282,285,288,291,294,297,300,303,306,309,312,315],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"LIF","Dialyzer Reprocessing System",57,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"FJG","Dialyzer, Parallel Flow",36,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FIB","Protector, Transducer, Dialysis",35,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"FIN","Tank, Holding, Dialysis",18,{"product_code":152,"device_name":153,"device_class":8,"k510_count":150},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"FHS","Dialyzer, Single Coil",12,{"product_code":163,"device_name":164,"device_class":8,"k510_count":161},"FKR","Subsystem, Proportioning",{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":170,"device_name":171,"device_class":8,"k510_count":168},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":177,"device_name":178,"device_class":8,"k510_count":175},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":184,"device_name":185,"device_class":12,"k510_count":182},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":187,"device_name":188,"device_class":8,"k510_count":182},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":190,"device_name":191,"device_class":8,"k510_count":182},"MNV","Strip, Dialysate Ph Indicator",{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":197,"device_name":198,"device_class":8,"k510_count":195},"FJF","Detector, Air Bubble",{"product_code":200,"device_name":201,"device_class":8,"k510_count":195},"FJT","Intracatheter, Dialysis",{"product_code":203,"device_name":204,"device_class":8,"k510_count":195},"FKJ","Filter, Blood, Dialysis",{"product_code":206,"device_name":207,"device_class":8,"k510_count":208},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":210,"device_name":211,"device_class":8,"k510_count":208},"FJD","Detector, Leak, Blood",{"product_code":213,"device_name":214,"device_class":8,"k510_count":208},"FKY","Connector, Tubing, Dialysate",{"product_code":216,"device_name":217,"device_class":8,"k510_count":208},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":219,"device_name":220,"device_class":8,"k510_count":208},"KXM","System Accessories, Extracorporeal",{"product_code":222,"device_name":223,"device_class":8,"k510_count":208},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":225,"device_name":226,"device_class":8,"k510_count":35},"FID","Tubing, Dialysate",{"product_code":228,"device_name":229,"device_class":8,"k510_count":35},"FJB","Detector, Dialysate Level",{"product_code":231,"device_name":232,"device_class":8,"k510_count":35},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":234,"device_name":235,"device_class":8,"k510_count":35},"FKI","Set, Dialyzer Holder",{"product_code":237,"device_name":238,"device_class":8,"k510_count":239},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":241,"device_name":242,"device_class":8,"k510_count":239},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":244,"device_name":245,"device_class":8,"k510_count":36},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",{"product_code":247,"device_name":248,"device_class":8,"k510_count":36},"FIW","Alarm, Pillow Pressure",{"product_code":250,"device_name":251,"device_class":8,"k510_count":36},"FJC","Detector, Blood Level",{"product_code":253,"device_name":254,"device_class":8,"k510_count":36},"FKD","Canister, Coil",{"product_code":256,"device_name":257,"device_class":8,"k510_count":36},"FKL","Insert, Pump, Blood",{"product_code":259,"device_name":260,"device_class":8,"k510_count":36},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":262,"device_name":263,"device_class":8,"k510_count":36},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":265,"device_name":266,"device_class":8,"k510_count":36},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":268,"device_name":269,"device_class":12,"k510_count":33},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":271,"device_name":272,"device_class":8,"k510_count":33},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":274,"device_name":275,"device_class":8,"k510_count":33},"FIS","Flowmeter, Dialysate",{"product_code":277,"device_name":278,"device_class":8,"k510_count":33},"FJA","Manometer, Water",{"product_code":280,"device_name":281,"device_class":8,"k510_count":33},"FJJ","Dialyzer, Twin Coil",{"product_code":283,"device_name":284,"device_class":8,"k510_count":33},"FJP","Adaptor, Y",{"product_code":286,"device_name":287,"device_class":12,"k510_count":33},"FKE","Tie, Dialysis",{"product_code":289,"device_name":290,"device_class":12,"k510_count":33},"FKF","Gun, Tie, Dialysis",{"product_code":292,"device_name":293,"device_class":8,"k510_count":33},"FKM","Adaptor, Fistula",{"product_code":295,"device_name":296,"device_class":8,"k510_count":33},"KQR","Detector, Air Or Foam",{"product_code":298,"device_name":299,"device_class":12,"k510_count":33},"MON","System, Hemodialysis, Remote Accessories",{"product_code":301,"device_name":302,"device_class":8,"k510_count":33},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":304,"device_name":305,"device_class":8,"k510_count":33},"PEV","Dialysis Administration Kit",{"product_code":307,"device_name":308,"device_class":8,"k510_count":33},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":310,"device_name":311,"device_class":8,"k510_count":33},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":313,"device_name":314,"device_class":8,"k510_count":33},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":316,"device_name":317,"device_class":8,"k510_count":33},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":319,"classification":320,"enforcement":321,"event":322,"pma":323,"warning_letter":324},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":326,"definition_ja":34,"commentary_ja":327,"model_name":328,"source_hash":329,"reviewed_by":34,"reviewed_at":34,"created_at":330,"updated_at":330},"透析用温度モニタ","本品は透析治療において体温または透析液温度を監視するための機器です。米国ではクラスIIに分類されており、市販前届出（510(k)）により既存の同等な機器との実質的同等性を示すことで市販が認められる審査区分となっています。","claude-sonnet-5","ec3e544dd03592d2f1dc09b5c68e7faf31aa89da0b7cdfe43de306e67c252a95","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":332,"stats":333,"stats_hash":343,"model_name":328,"created_at":344,"updated_at":344},"510(k)の累計件数は3件、参入企業数は3社で、最新の判定は2014年6月となっており、直近5年間の届出は確認されていません。不具合報告は累計1件で、Malfunction（不具合）が中心であり、死亡・傷害の報告は確認されていません。回収については累計件数0件で、クラスI・II・IIIのいずれも確認されていません。",{"pma":334,"k510":335,"as_of":337,"events":338,"recalls":340,"top_problems":342},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":336,"applicants":35},"2014-06-16","2026-08",{"death":33,"other":33,"total":36,"injury":33,"last5y":36,"malfunction":36,"latest_month":339},"2026-05",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":341},[],[],"6f531d3d24cadaa8ebd4f8ee5ff95cfcfb33d3354f6b48ada7b4ae2b138a811f","2026-08-24T04:21:40.396908+00:00",{"items":346,"total":33},[],{"items":348,"total":35},[349,355,360],{"k_number":21,"device_name":350,"applicant":351,"decision_date":336,"clearance_type":352,"decision_code":353,"statement_or_summary":354},"NXSTAGE EXPRESS FLUID WARMER","Nxstage Medical, Inc.","Special","SESE","Summary",{"k_number":19,"device_name":356,"applicant":357,"decision_date":358,"clearance_type":359,"decision_code":353,"statement_or_summary":34},"FLUID WARMER","Organon Teknika Corp.","1984-08-27","Traditional",{"k_number":20,"device_name":361,"applicant":362,"decision_date":363,"clearance_type":359,"decision_code":353,"statement_or_summary":34},"FLO-TEMP","Laminar Flow Industries","1981-01-23",{"items":365,"total":33},[]]