[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KSI":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":110,"syncDates":111,"translation":118,"marketSummary":124,"recalls":141,"k510s":143,"pmas":159},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":40},2026,"KSI","Lectins And Protectins","2","864.9550","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":22,"registration_number":31},[18,19,20,21],"K792583","K813413","K792582","K820368",[23,24,25,26,27,28,29,30],"3012963943","3011683976","1000136573","3002642396","3000308930","2250051","3017237798","1034569",[23,24,32,26,27,28,29,30],"1319681","N","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:48.758894+00:00",0,null,4,701,[],[43,51,59,66,72,79,85,92,98,104],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":37,"vector_similarity":49,"score":50},3305,"放射線防護用ミトン","Ⅰ","38365000",0.228571,0.549751,0.0272222,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":37,"vector_similarity":57,"score":58},3208,"家庭用鼻腔粘膜保護材","Ⅱ","60371002",0.166667,0.5487,0.0243938,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":37,"definition_similarity":37,"vector_similarity":64,"score":65},1121,"ヘパリン使用眼内ドレーン","Ⅲ","61127003",0.593017,0.0163934,{"medical_device_id":67,"generic_name":68,"class_classification":54,"jmdn_code":69,"name_similarity":70,"definition_similarity":37,"vector_similarity":71,"score":65},2253,"創傷保護リング","44273000",0.357143,0.501589,{"medical_device_id":73,"generic_name":74,"class_classification":62,"jmdn_code":75,"name_similarity":76,"definition_similarity":37,"vector_similarity":77,"score":78},474,"ヘパリン使用成分採血セット","70405000",0.0217391,0.583312,0.016129,{"medical_device_id":80,"generic_name":81,"class_classification":46,"jmdn_code":82,"name_similarity":83,"definition_similarity":37,"vector_similarity":84,"score":78},3302,"放射線防護用前掛","38355000",0.290323,0.494036,{"medical_device_id":86,"generic_name":87,"class_classification":62,"jmdn_code":88,"name_similarity":89,"definition_similarity":37,"vector_similarity":90,"score":91},1059,"コラーゲン使用眼防護具","17652000",0.162791,0.572294,0.015873,{"medical_device_id":93,"generic_name":94,"class_classification":46,"jmdn_code":95,"name_similarity":96,"definition_similarity":37,"vector_similarity":97,"score":91},3661,"保護栓","70280000",0.266667,0.463576,{"medical_device_id":99,"generic_name":100,"class_classification":54,"jmdn_code":101,"name_similarity":96,"definition_similarity":37,"vector_similarity":102,"score":103},2132,"保護用オーバーチューブ","70334000",0.498016,0.015625,{"medical_device_id":105,"generic_name":106,"class_classification":54,"jmdn_code":107,"name_similarity":108,"definition_similarity":37,"vector_similarity":109,"score":103},2647,"歯科矯正用長期粘膜保護材","70738000",0.153846,0.570203,[],{"510k":112,"classification":113,"enforcement":114,"event":115,"pma":116,"warning_letter":117},"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":119,"definition_ja":38,"commentary_ja":120,"model_name":121,"source_hash":122,"reviewed_by":38,"reviewed_at":38,"created_at":123,"updated_at":123},"レクチン及びプロテクチン","この製品は、血液学領域で赤血球や白血球などの血球の凝集反応を利用した検査に用いられるレクチン及びプロテクチン試薬です。米国ではクラスIIに分類されていますが、510(k)による市販前届出が免除されている点が特徴です。","claude-sonnet-5","df2152cee02258bfd88ad08cd6097245ec2b0e7edc79676d328a6a07c0d27702","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":125,"stats":126,"stats_hash":139,"model_name":121,"created_at":140,"updated_at":140},"本製品コードは届出免除（510(k) Exempt）のクラスII機器で、510(k)の累計件数は4件、参入企業数は2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（MDR）は累計約700件で、そのほぼすべてがMalfunction（不具合）として報告されており、死亡・傷害の報告は確認されていません。主な問題としては「Incorrect, Inadequate or Imprecise Result or Readings」が挙げられています。回収（リコール）は累計0件で、クラスI〜IIIいずれの事例も確認されていません。",{"pma":127,"k510":128,"as_of":131,"events":132,"recalls":135,"top_problems":137},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":37,"latest":129,"applicants":130},"1982-04-14",2,"2026-08",{"death":37,"other":37,"total":40,"injury":37,"last5y":133,"malfunction":40,"latest_month":134},700,"2025-11",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":136},[],[138],"Incorrect, Inadequate or Imprecise Result or Readings","12f7d441a63a02976a217618ff1e7085dcdb044f10510174b031b9a5b00a06c9","2026-08-24T04:46:30.426153+00:00",{"items":142,"total":37},[],{"items":144,"total":39},[145,150,153,157],{"k_number":21,"device_name":146,"applicant":147,"decision_date":129,"clearance_type":148,"decision_code":149,"statement_or_summary":38},"LECTIN-A","American Dade","Traditional","SESE",{"k_number":19,"device_name":151,"applicant":147,"decision_date":152,"clearance_type":148,"decision_code":149,"statement_or_summary":38},"LECTIN H","1982-03-04",{"k_number":18,"device_name":154,"applicant":155,"decision_date":156,"clearance_type":148,"decision_code":149,"statement_or_summary":38},"GAMMA ARACHIS HYPOGEA LECTIN","Gamma Biologicals, Inc.","1980-01-16",{"k_number":20,"device_name":158,"applicant":155,"decision_date":156,"clearance_type":148,"decision_code":149,"statement_or_summary":38},"POLY-LEC SYSTEM",{"items":160,"total":37},[]]