[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-ORC":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":122,"syncDates":145},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":36,"event_count":36},6885,"ORC","Air Filter Portable Apparatus","2","878.5070","SU","General, Plastic Surgery","HO","1","The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":12,"gmp_exempt_flag":31,"third_party_flag":32,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":33},{"k_number":18,"fei_number":25,"registration_number":28},[19,20,21,22,23,24],"K190027","K173349","K153498","K163455","K092801","K123006",[26,27],"3002807038","3012992602",[29,27],"3009756327","","N","Y","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",0,null,6,[],[41,50,58,67,74,82,91,99,107,114],{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},2181,"注射筒用フィルタ","Ⅱ","15283000",0.189189,0.176871,0.730519,0.0293236,{"medical_device_id":51,"generic_name":52,"class_classification":44,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},2401,"吸引装置用除菌フィルタ","37798000",0.166667,0.254902,0.746233,0.0290517,{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},466,"ポータブル持続麻酔用ユニット","Ⅲ","70395000",0.2,0.111111,0.704722,0.0290404,{"medical_device_id":68,"generic_name":69,"class_classification":44,"jmdn_code":70,"name_similarity":63,"definition_similarity":71,"vector_similarity":72,"score":73},2274,"麻酔用フィルタ","70450000",0.0607735,0.734373,0.0289495,{"medical_device_id":75,"generic_name":76,"class_classification":44,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},2624,"可搬式歯科用ユニット","70725000",0.219512,0.167539,0.680356,0.0282832,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},3924,"人工呼吸器フィルタ","Ⅰ","14352000",0.175,0.178744,0.731452,0.0277778,{"medical_device_id":92,"generic_name":93,"class_classification":85,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},3597,"再使用可能なフィルタ付針","16266001",0.243902,0.143713,0.635696,0.0163934,{"medical_device_id":100,"generic_name":101,"class_classification":61,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},747,"血液成分分離用フィルタ","36194000",0.243243,0.108108,0.656986,0.016129,{"medical_device_id":108,"generic_name":109,"class_classification":44,"jmdn_code":110,"name_similarity":95,"definition_similarity":111,"vector_similarity":112,"score":113},2961,"温灸器","71018000",0.0986842,0.551234,0.015873,{"medical_device_id":115,"generic_name":116,"class_classification":44,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},2399,"呼吸回路除菌用フィルタ","35070000",0.148936,0.254545,0.724942,0.0153846,[123,127,131,135,139,142],{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FYD","Apparatus, Exhaust, Surgical",75,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"FZI","Apparatus, Air Handling, Enclosure",5,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"FZH","Apparatus, Air Handling, Room",4,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FZG","Apparatus, Air Handling, Bench",1,{"product_code":140,"device_name":141,"device_class":8,"k510_count":36},"FLJ","Unit, Airflow, Laminar",{"product_code":143,"device_name":144,"device_class":8,"k510_count":36},"FRT","Unit, Isolation, Surgical",{"510k":146,"classification":147,"enforcement":148,"event":149,"pma":150,"warning_letter":151},"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"]