[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KFJ":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":105,"syncDates":106,"translation":113,"marketSummary":119,"recalls":137,"k510s":139,"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":30},2194,"KFJ","Materials, Repair Or Replacement, Pacemaker","3","870.3710","CV","Cardiovascular","2","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":18},[19,20,21],"K813518","K852236","K913919","Y","N","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:48.095002+00:00",0,null,3,10,[],[33,41,49,56,64,71,78,85,92,98],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":27,"vector_similarity":39,"score":40},4435,"体外式ペースメーカ用ケーブル及びアダプタ","Ⅰ","71061001",0.241379,0.694942,0.0305361,{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":27,"vector_similarity":47,"score":48},541,"植込み型ペースメーカバッグ","Ⅲ","16038000",0.211538,0.701461,0.0287829,{"medical_device_id":50,"generic_name":51,"class_classification":44,"jmdn_code":52,"name_similarity":53,"definition_similarity":27,"vector_similarity":54,"score":55},543,"ペースメーカ充電器","33658000",0.227273,0.661031,0.0274798,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":27,"vector_similarity":62,"score":63},206,"植込み型ペースメーカアダプタ","Ⅳ","36102000",0.218182,0.661739,0.0272222,{"medical_device_id":65,"generic_name":66,"class_classification":59,"jmdn_code":67,"name_similarity":68,"definition_similarity":27,"vector_similarity":69,"score":70},200,"植込み型心臓ペースメーカ","12913000",0.196429,0.680508,0.0269439,{"medical_device_id":72,"generic_name":73,"class_classification":59,"jmdn_code":74,"name_similarity":75,"definition_similarity":27,"vector_similarity":76,"score":77},202,"植込み型両心室同期ペースメーカ","70484009",0.196721,0.678477,0.026905,{"medical_device_id":79,"generic_name":80,"class_classification":44,"jmdn_code":81,"name_similarity":82,"definition_similarity":27,"vector_similarity":83,"score":84},540,"ペースメーカプログラマ","15993000",0.217391,0.652523,0.0260443,{"medical_device_id":86,"generic_name":87,"class_classification":59,"jmdn_code":88,"name_similarity":89,"definition_similarity":27,"vector_similarity":90,"score":91},203,"心外膜植込み型ペースメーカリード","35039000",0.166667,0.718656,0.0163934,{"medical_device_id":93,"generic_name":94,"class_classification":59,"jmdn_code":95,"name_similarity":96,"definition_similarity":27,"vector_similarity":97,"score":91},1092,"冠動脈カテーテル交換用カテーテル","17846124",0.280702,0.620466,{"medical_device_id":99,"generic_name":100,"class_classification":59,"jmdn_code":101,"name_similarity":102,"definition_similarity":27,"vector_similarity":103,"score":104},204,"心内膜植込み型ペースメーカリード","35223000",0.164384,0.714619,0.016129,[],{"510k":107,"classification":108,"enforcement":109,"event":110,"pma":111,"warning_letter":112},"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":114,"definition_ja":28,"commentary_ja":115,"model_name":116,"source_hash":117,"reviewed_by":28,"reviewed_at":28,"created_at":118,"updated_at":118},"ペースメーカ修理・交換用材料","本品は、ペースメーカの修理または交換に用いられる材料を指す製品分類です。米国ではクラスIIIに分類されており、市販前に有効性と安全性を実証するための市販前承認（PMA）を取得する必要があります。クラスIIIは米国の医療機器規制における最も規制が厳しい区分であり、生命維持や健康に重大な影響を及ぼす可能性がある機器が対象となります。","claude-sonnet-5","6fd7691c3ce0570bed5438dcde4374f40249467bb441a6a3a1f9793ff79c465d","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":120,"stats":121,"stats_hash":135,"model_name":116,"created_at":136,"updated_at":136},"本製品分野は510(k)の累計件数が3件、参入企業数は3社ですが、直近5年の届出は確認されておらず、最新の判定も1991年12月にとどまっています。不具合報告は累計約10件で、内訳は不具合（Malfunction）が8件、傷害が2件、死亡は確認されていません。主な問題としてはセットアップ・準備の困難さ（Device Difficult to Setup or Prepare）や接続の緩み・断続（Loose or Intermittent Connection）が挙げられています。回収の実績は確認されていません。",{"pma":122,"k510":123,"as_of":125,"events":126,"recalls":130,"top_problems":132},{"latest":28,"originals":27,"supplements":27},{"total":29,"last5y":27,"latest":124,"applicants":29},"1991-12-31","2026-08",{"death":27,"other":27,"total":30,"injury":127,"last5y":127,"malfunction":128,"latest_month":129},2,8,"2023-08",{"total":27,"last5y":27,"latest":28,"class_i":27,"class_ii":27,"class_iii":27,"top_root_causes":131},[],[133,134],"Device Difficult to Setup or Prepare","Loose or Intermittent Connection","30bd230450b97cca2fc9fc9f9fccd08405be45660590f271294220de8e19dfe3","2026-08-24T04:44:46.948226+00:00",{"items":138,"total":27},[],{"items":140,"total":29},[141,147,151],{"k_number":21,"device_name":142,"applicant":143,"decision_date":124,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"UNIVERSAL TERMINAL CAP, 3.2MM","Telectronics Pacing Systems, Inc.","Traditional","SESE","Summary",{"k_number":20,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":144,"decision_code":145,"statement_or_summary":28},"MEDTRONIC MODEL 5867-1A","Medtronic Vascular","1985-07-11",{"k_number":19,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":144,"decision_code":145,"statement_or_summary":28},"IMPLANT AID SPLICING CRIMP & SLEEVE","Intermedics, Inc.","1982-01-12",{"items":156,"total":27},[]]