[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KMG":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":114,"syncDates":115,"translation":122,"marketSummary":128,"recalls":142,"k510s":144,"pmas":174},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":39},6992,"KMG","Purifier, Water, Ultraviolet, Medical","2","880.6710","HO","General Hospital","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":27,"registration_number":33},[18,19,20,21,22,23,24,25,26],"K831253","K832288","K813050","K012029","K813045","K813049","K813046","K813047","K813048",[28,29,30,31,32],"3027509245","3017125427","1000125241","3043572677","3014150341",[34,28,29,31,32],"2028411","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.225237+00:00",0,null,9,[],[44,52,59,65,72,79,87,94,101,107],{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":39,"vector_similarity":50,"score":51},2345,"紫外線浄水装置","Ⅱ","35435000",0.568182,0.726337,0.0327869,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":39,"vector_similarity":57,"score":58},2456,"腹膜灌流用紫外線照射器","17434000",0.208955,0.662153,0.0312576,{"medical_device_id":60,"generic_name":61,"class_classification":47,"jmdn_code":62,"name_similarity":63,"definition_similarity":39,"vector_similarity":64,"score":58},2956,"家庭用紫外線治療器","71013000",0.2,0.685578,{"medical_device_id":66,"generic_name":67,"class_classification":47,"jmdn_code":68,"name_similarity":69,"definition_similarity":39,"vector_similarity":70,"score":71},2466,"紫外線治療器","35149000",0.230769,0.638029,0.0304147,{"medical_device_id":73,"generic_name":74,"class_classification":47,"jmdn_code":75,"name_similarity":76,"definition_similarity":39,"vector_similarity":77,"score":78},2275,"酸素吸入加温加湿装置用水","70452002",0.130435,0.686383,0.016129,{"medical_device_id":80,"generic_name":81,"class_classification":82,"jmdn_code":83,"name_similarity":84,"definition_similarity":39,"vector_similarity":85,"score":86},1185,"前立腺組織用水蒸気デリバリーシステム","Ⅲ","71095003",0.0909091,0.675011,0.015625,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":39,"vector_similarity":93,"score":86},3931,"単回使用汎用ウォータトラップ","Ⅰ","41679000",0.20339,0.556445,{"medical_device_id":95,"generic_name":96,"class_classification":82,"jmdn_code":97,"name_similarity":98,"definition_similarity":39,"vector_similarity":99,"score":100},754,"吸着型血液浄化用装置","35104010",0.134328,0.653979,0.0151515,{"medical_device_id":102,"generic_name":103,"class_classification":47,"jmdn_code":104,"name_similarity":105,"definition_similarity":39,"vector_similarity":106,"score":100},1304,"超音波増幅器","36370000",0.195652,0.485227,{"medical_device_id":108,"generic_name":109,"class_classification":47,"jmdn_code":110,"name_similarity":111,"definition_similarity":39,"vector_similarity":112,"score":113},1996,"経皮洗浄向け泌尿器用カテーテル","34930020",0.0985916,0.644901,0.0149254,[],{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":40,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":40,"reviewed_at":40,"created_at":127,"updated_at":127},"紫外線式医療用浄水器","本機器は、紫外線を利用して医療現場で使用する水を浄化する装置です。米国ではクラスIIに分類されていますが、510(k)の届出が免除される区分とされており、通常のクラスII機器に求められる市販前届出の手続きを経ずに市販することが認められています。","claude-sonnet-5","2fe69ab7ef15118a6897a5526830515ab55e5b94834cea5a705b47920a7cee4b","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":140,"model_name":125,"created_at":141,"updated_at":141},"本製品コードは届出免除の区分ですが、510(k)としての累計届出は9件、参入企業数は4社となっており、直近5年間の届出はありません。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、確認されていません。",{"pma":131,"k510":132,"as_of":135,"events":136,"recalls":137,"top_problems":139},{"latest":40,"originals":39,"supplements":39},{"total":41,"last5y":39,"latest":133,"applicants":134},"2001-12-31",4,"2026-08",{"death":39,"other":39,"total":39,"injury":39,"last5y":39,"malfunction":39,"latest_month":40},{"total":39,"last5y":39,"latest":40,"class_i":39,"class_ii":39,"class_iii":39,"top_root_causes":138},[],[],"e303d027b52ac2cbb95eaab08437fbe56a74034f6a29ba1b014252d9055c66d5","2026-08-24T04:46:30.426153+00:00",{"items":143,"total":39},[],{"items":145,"total":41},[146,152,156,160,164,166,168,170,172],{"k_number":21,"device_name":147,"applicant":148,"decision_date":133,"clearance_type":149,"decision_code":150,"statement_or_summary":151},"REMEDY MODEL 2Z12","Apollo Corp.","Traditional","SESE","Summary",{"k_number":19,"device_name":153,"applicant":154,"decision_date":155,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"HEMOGLOBINOMETER","Mallinckrodt Critical Care","1983-09-01",{"k_number":18,"device_name":157,"applicant":158,"decision_date":159,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"LANCER HEMOGLOBIN ANALYZER REAGENTS","Sherwood Medical Co.","1983-05-09",{"k_number":20,"device_name":161,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, #MP4SF","Cooper-Hewitt Electric Co.","1981-12-02",{"k_number":23,"device_name":165,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, #HHU100",{"k_number":26,"device_name":167,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, #MP2SF",{"k_number":25,"device_name":169,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, MINI 60L",{"k_number":24,"device_name":171,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, #HHU60",{"k_number":22,"device_name":173,"applicant":162,"decision_date":163,"clearance_type":149,"decision_code":150,"statement_or_summary":40},"AQUANOMICS, #SP36SF",{"items":175,"total":39},[]]