[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PKP":3},{"classification":4,"mappedDevices":49,"similarCandidates":50,"relatedClassifications":134,"syncDates":197},{"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":44,"updated_at":45,"recall_count":46,"latest_recall_date":47,"k510_count":48,"pma_count":46,"event_count":48},3054,"PKP","Immunoglobulin G (Igg) Infusion System","2","880.5725","HO","General Hospital","1","An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":41,"device_class":8,"implant_flag":42,"product_code":6,"review_panel":10,"gmp_exempt_flag":42,"third_party_flag":42,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":41,"life_sustain_support_flag":42,"medical_specialty_description":11,"summary_malfunction_reporting":43},{"k_number":17,"fei_number":25,"registration_number":37},[18,19,20,21,22,23,24],"K161906","K251105","K222087","K230883","K240148","K142319","K173783",[26,27,28,29,30,31,32,33,34,35,36],"3018229072","2937446","3036773433","3008132411","3007428065","3024122953","3003927385","2523167","1000226372","3010236732","1000136478",[26,28,29,38,30,39,31,32,33,35,40],"9680306","1319660","3008570882","","N","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",0,null,7,[],[51,60,69,77,85,93,102,110,118,126],{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},449,"注射筒輸液ポンプ","Ⅲ","13217000",0.23913,0.189103,0.687243,0.0315136,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},2173,"インスリンポンプ用輸液セット","Ⅱ","35838000",0.220339,0.16568,0.681973,0.0294181,{"medical_device_id":70,"generic_name":71,"class_classification":54,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},455,"ポータブルインスリン用輸液ポンプ","35983000",0.235294,0.276018,0.667265,0.0293805,{"medical_device_id":78,"generic_name":79,"class_classification":63,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},1414,"インフュージョンポンプ","70058000",0.225,0.150685,0.677024,0.0290404,{"medical_device_id":86,"generic_name":87,"class_classification":54,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},448,"汎用輸液ポンプ","13215000",0.188679,0.19863,0.694474,0.0286935,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},3747,"経腸栄養注入セット","Ⅰ","70400000",0.2,0.198895,0.680998,0.0282194,{"medical_device_id":103,"generic_name":104,"class_classification":63,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2180,"ポンプ用経腸栄養注入セット","70376000",0.169492,0.257426,0.679915,0.0253968,{"medical_device_id":111,"generic_name":112,"class_classification":63,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},2067,"注入用カテーテル","33172000",0.204545,0.165714,0.657665,0.0252381,{"medical_device_id":119,"generic_name":120,"class_classification":63,"jmdn_code":121,"name_similarity":122,"definition_similarity":123,"vector_similarity":124,"score":125},2192,"医薬品・ワクチン用注入器","12504002",0.0588235,0.193548,0.711694,0.0163934,{"medical_device_id":127,"generic_name":128,"class_classification":63,"jmdn_code":129,"name_similarity":130,"definition_similarity":131,"vector_similarity":132,"score":133},1848,"医薬品・ワクチン注入用注射筒","12132000",0.1,0.208723,0.700065,0.016129,[135,139,143,147,151,155,159,163,167,171,175,178,181,185,189,193],{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FRN","Pump, Infusion",849,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"MEB","Pump, Infusion, Elastomeric",88,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"LZG","Pump, Infusion, Insulin",84,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"LGZ","Warmer, Thermal, Infusion Fluid",75,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"LDR","Controller, Infusion, Intravascular, Electronic",60,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"MRZ","Accessories, Pump, Infusion",48,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"LZH","Pump, Infusion, Enteral",34,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"MEA","Pump, Infusion, Pca",31,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"MRH","Pump, Infusion, Ophthalmic",20,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"PHC","Infusion Safety Management Software",10,{"product_code":176,"device_name":177,"device_class":8,"k510_count":48},"LZF","Pump, Infusion, Analytical Sampling",{"product_code":179,"device_name":180,"device_class":8,"k510_count":48},"OPP","Pump, Infusion, Insulin Bolus",{"product_code":182,"device_name":183,"device_class":8,"k510_count":184},"PMS","Peripheral Intravenous (Piv) Infiltration Monitor",5,{"product_code":186,"device_name":187,"device_class":8,"k510_count":188},"QJY","Infusion Pump, Drug Specific, Pharmacy-Filled",4,{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"LHF","Warmer, Microwave, Infusion Fluid",2,{"product_code":194,"device_name":195,"device_class":8,"k510_count":196},"MHD","Pump, Infusion, Gallstone Dissolution",1,{"510k":198,"classification":199,"enforcement":200,"event":201,"pma":202,"warning_letter":203},"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","2026-08-18T06:42:29.411+00:00"]