[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OKL":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":111,"syncDates":112,"translation":119,"marketSummary":126,"recalls":139,"k510s":141,"pmas":155},{"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":14,"gmp_exempt_flag":14,"raw":15,"created_at":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":25,"event_count":25},4903,"OKL","Intravascular Administration Set, Automated Air Removal System","2","880.5445","HO","General Hospital","1","An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":20,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":10,"gmp_exempt_flag":21,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":20,"life_sustain_support_flag":21,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17},[18,19],"DEN080009","K171954","","N","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.882786+00:00",0,null,2,[],[30,39,47,55,64,72,80,88,96,104],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":36,"vector_similarity":37,"score":38},2172,"輸液ポンプ用輸液セット","Ⅱ","35833000",0.308824,0.213483,0.719876,0.0322665,{"medical_device_id":40,"generic_name":41,"class_classification":33,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},2176,"自然落下式・ポンプ接続兼用輸液セット","70371000",0.278481,0.222222,0.729835,0.0306792,{"medical_device_id":48,"generic_name":49,"class_classification":33,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},2174,"輸液セット用コントローラ","36244000",0.30137,0.224215,0.697958,0.0302135,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},445,"麻酔用輸液セット","Ⅲ","70375000",0.283784,0.204461,0.716651,0.0301178,{"medical_device_id":65,"generic_name":66,"class_classification":33,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},2178,"造影剤用輸液セット","70373000",0.289474,0.215385,0.70917,0.0298507,{"medical_device_id":73,"generic_name":74,"class_classification":33,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},2170,"ノンコアリングニードル付静脈内投与セット","17701000",0.282353,0.32381,0.69694,0.0297619,{"medical_device_id":81,"generic_name":82,"class_classification":33,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},2175,"熱交換機能付静脈内投与セット","41609000",0.269663,0.232804,0.695137,0.0274024,{"medical_device_id":89,"generic_name":90,"class_classification":33,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},1588,"X線CT診断装置キセノンガス管理システム","40907000",0.295455,0.214035,0.687163,0.0270125,{"medical_device_id":97,"generic_name":98,"class_classification":58,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},806,"一酸化窒素ガス管理システム","37266000",0.293333,0.209091,0.686085,0.0263875,{"medical_device_id":105,"generic_name":106,"class_classification":33,"jmdn_code":107,"name_similarity":60,"definition_similarity":108,"vector_similarity":109,"score":110},2173,"インスリンポンプ用輸液セット","35838000",0.17033,0.689839,0.0259893,[],{"510k":113,"classification":114,"enforcement":115,"event":116,"pma":117,"warning_letter":118},"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":120,"definition_ja":121,"commentary_ja":122,"model_name":123,"source_hash":124,"reviewed_by":26,"reviewed_at":26,"created_at":125,"updated_at":125},"血管内投与セット用自動気泡除去装置","血管内投与セット用自動気泡除去システムは、静脈内輸液の流れを中断することなく、または最小限の中断で、血管内投与セットから空気を検出し自動的に除去するために使用される処方箋医療機器である。","本機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）による審査を経て市場に流通します。クラスIIは中程度のリスクを有する医療機器を対象とし、性能規格の適合などにより安全性・有効性が確認される区分です。","claude-sonnet-5","e79df6698cd98906e4065bb929cf190c09daddbdd0abc7ca0d626249ce821c55","2026-08-24T02:21:53.785012+00:00",{"product_code":6,"summary_ja":127,"stats":128,"stats_hash":137,"model_name":123,"created_at":138,"updated_at":138},"510(k)の累計届出件数は2件、参入企業数は2社で、最新の判定は2018年1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。不具合報告および回収については、いずれも累計件数が0件であり、報告・実施の実績は確認されていません。",{"pma":129,"k510":130,"as_of":132,"events":133,"recalls":134,"top_problems":136},{"latest":26,"originals":25,"supplements":25},{"total":27,"last5y":25,"latest":131,"applicants":27},"2018-01-25","2026-08",{"death":25,"other":25,"total":25,"injury":25,"last5y":25,"malfunction":25,"latest_month":26},{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":135},[],[],"489e96b4e260aa818dd3445a404211dbab4a7f12c7ef288cb8e0b0c3250966aa","2026-08-24T05:03:24.690751+00:00",{"items":140,"total":25},[],{"items":142,"total":27},[143,149],{"k_number":19,"device_name":144,"applicant":145,"decision_date":131,"clearance_type":146,"decision_code":147,"statement_or_summary":148},"ClearLine IV","Clearline MD","Traditional","SESE","Summary",{"k_number":18,"device_name":150,"applicant":151,"decision_date":152,"clearance_type":153,"decision_code":154,"statement_or_summary":26},"AIRPURGE","Anesthesia Safety Products, LLC","2014-03-04","Post-NSE","DENG",{"items":156,"total":25},[]]