[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ODN":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":114,"syncDates":134},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},582,"ODN","Ultrafiltration-Controlled Nocturnal Dialysate Delivery System","2","876.5860","GU","Gastroenterology, Urology","1","Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.  Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":18},[19,20],"K150472","K141752","","N","Y","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,[],[32,41,49,57,65,73,81,89,97,106],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},693,"多人数用透析液供給装置","Ⅲ","34993000",0.283951,0.185714,0.806219,0.0325225,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},708,"血液透析濾過用装置","70520000",0.268657,0.309859,0.795743,0.0322665,{"medical_device_id":50,"generic_name":51,"class_classification":35,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},692,"透析用監視装置","36424000",0.266667,0.159292,0.741095,0.031498,{"medical_device_id":58,"generic_name":59,"class_classification":35,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},704,"透析用血液循環ユニット","36428000",0.22619,0.159204,0.711448,0.0296313,{"medical_device_id":66,"generic_name":67,"class_classification":35,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},695,"多用途透析装置","34994020",0.186667,0.274038,0.719314,0.0288501,{"medical_device_id":74,"generic_name":75,"class_classification":35,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},820,"自動腹膜灌流用装置","11226000",0.197531,0.150628,0.722752,0.0280428,{"medical_device_id":82,"generic_name":83,"class_classification":35,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},761,"持続緩徐式血液濾過用装置","70541000",0.25974,0.166667,0.671839,0.0271193,{"medical_device_id":90,"generic_name":91,"class_classification":35,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},691,"人工腎臓装置","34995000",0.15942,0.28,0.804154,0.016129,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1182,"心臓用補綴材留置用デリバリーシステム","Ⅳ","45419004",0.237624,0.18,0.626418,0.0153846,{"medical_device_id":107,"generic_name":108,"class_classification":35,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},753,"血液濾過用装置","35453000",0.242424,0.129213,0.667775,0.0151515,[115,119,123,127,131],{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"KDI","Dialyzer, High Permeability With Or Without Sealed Dialysate System",345,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"MSF","Hemodialyzer, Re-Use, High Flux",8,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FII","System, Dialysate Delivery, Sealed",5,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"ONW","Hemodialysis System For Home Use",4,{"product_code":132,"device_name":133,"device_class":8,"k510_count":29},"NII","Disinfectant, Dialysate Delivery System",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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","2026-08-19T04:07:02.603+00:00"]