[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KSE":3},{"classification":4,"mappedDevices":71,"similarCandidates":72,"relatedClassifications":142,"syncDates":143,"translation":150,"marketSummary":156,"recalls":174,"k510s":176,"pmas":195},{"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":65,"updated_at":66,"recall_count":67,"latest_recall_date":68,"k510_count":69,"pma_count":67,"event_count":70},5361,"KSE","Refrigerator, Freezer, Blood Storage","2","864.9700","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":63,"product_code":6,"review_panel":10,"gmp_exempt_flag":63,"third_party_flag":63,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":63,"medical_specialty_description":11,"summary_malfunction_reporting":64},{"k_number":17,"fei_number":22,"registration_number":60},[18,19,20,21],"K802319","K800667","K813327","K884436",[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"3009963993","3031700059","3042991841","3009141585","1000123765","3030516433","3042989733","3007123908","3009032016","1523845","3013846070","3002729000","3018296904","3017882410","3024595227","3004973569","1036832","3007127121","3022121584","3015060225","3012315023","3002821232","3005883510","3019916040","3043616309","3027645317","3031696823","3033918993","3009134624","3034286704","3010402964","3017667916","3012858319","3043138885","3038620105","3043088937","3006457401",[23,24,25,61,26,28,29,30,31,32,33,35,36,37,38,39,40,62,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"2950374","1424489","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.758894+00:00",0,null,4,382,[],[73,81,88,95,102,110,116,123,129,136],{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":67,"vector_similarity":79,"score":80},2355,"血液用冷蔵庫","Ⅱ","35486000",0.558824,0.825734,0.0327869,{"medical_device_id":82,"generic_name":83,"class_classification":76,"jmdn_code":84,"name_similarity":85,"definition_similarity":67,"vector_similarity":86,"score":87},2149,"採血セット","10426000",0.190476,0.649164,0.0305361,{"medical_device_id":89,"generic_name":90,"class_classification":76,"jmdn_code":91,"name_similarity":92,"definition_similarity":67,"vector_similarity":93,"score":94},2164,"血液・医薬品用加温器","10447000",0.166667,0.644512,0.0270516,{"medical_device_id":96,"generic_name":97,"class_classification":76,"jmdn_code":98,"name_similarity":99,"definition_similarity":67,"vector_similarity":100,"score":101},2459,"自己血回収装置","34863002",0.173913,0.618596,0.0253265,{"medical_device_id":103,"generic_name":104,"class_classification":105,"jmdn_code":106,"name_similarity":107,"definition_similarity":67,"vector_similarity":108,"score":109},333,"血液照射装置","Ⅲ","17437000",0.214286,0.546372,0.016129,{"medical_device_id":111,"generic_name":112,"class_classification":76,"jmdn_code":113,"name_similarity":114,"definition_similarity":67,"vector_similarity":115,"score":109},2148,"フローズバッグ","70359000",0.0714286,0.705474,{"medical_device_id":117,"generic_name":118,"class_classification":76,"jmdn_code":119,"name_similarity":120,"definition_similarity":67,"vector_similarity":121,"score":122},2163,"血液フィルタ","35071000",0.205128,0.597254,0.015873,{"medical_device_id":124,"generic_name":125,"class_classification":126,"jmdn_code":127,"name_similarity":67,"definition_similarity":67,"vector_similarity":128,"score":122},3748,"血漿融解装置","Ⅰ","43434000",0.693135,{"medical_device_id":130,"generic_name":131,"class_classification":76,"jmdn_code":132,"name_similarity":133,"definition_similarity":67,"vector_similarity":134,"score":135},1801,"胎児血液サンプラ","32662000",0.2,0.594623,0.015625,{"medical_device_id":137,"generic_name":138,"class_classification":126,"jmdn_code":139,"name_similarity":140,"definition_similarity":67,"vector_similarity":141,"score":135},3911,"哺乳瓶保温器","70479000",0.0727273,0.682145,[],{"510k":144,"classification":145,"enforcement":146,"event":147,"pma":148,"warning_letter":149},"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":151,"definition_ja":68,"commentary_ja":152,"model_name":153,"source_hash":154,"reviewed_by":68,"reviewed_at":68,"created_at":155,"updated_at":155},"血液保存用冷蔵庫・冷凍庫","本品は、輸血用血液や血液製剤を適切な温度で保管するための冷蔵庫または冷凍庫です。米国ではクラスIIに分類されていますが、510(k)（市販前届出）が免除されており、市販前の個別審査を経ずに市場に流通させることが可能です。","claude-sonnet-5","cf4462f75bf2607a69d193756465b96dd1e8a1029807f514094607430463d955","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":157,"stats":158,"stats_hash":172,"model_name":153,"created_at":173,"updated_at":173},"510(k)の累計件数は4件、参入企業数は4社で、直近5年間の届出はなく最新の判定は1988年12月となっています。不具合報告は累計約380件で、大半が不具合（Malfunction、約330件）によるものであり、死亡2件、傷害約30件、その他約30件が報告されています。直近5年間の報告はなく、最新の報告は2020年11月です。回収については確認されていません。",{"pma":159,"k510":160,"as_of":162,"events":163,"recalls":169,"top_problems":171},{"latest":68,"originals":67,"supplements":67},{"total":69,"last5y":67,"latest":161,"applicants":69},"1988-12-02","2026-08",{"death":164,"other":165,"total":70,"injury":166,"last5y":67,"malfunction":167,"latest_month":168},2,26,28,326,"2020-11",{"total":67,"last5y":67,"latest":68,"class_i":67,"class_ii":67,"class_iii":67,"top_root_causes":170},[],[],"7a326f8b0ce3fb74bbb00c9f23c0a79be5ebbac3a908f4dc6cf399a8baab03cd","2026-08-24T04:46:30.426153+00:00",{"items":175,"total":67},[],{"items":177,"total":69},[178,183,187,191],{"k_number":21,"device_name":179,"applicant":180,"decision_date":161,"clearance_type":181,"decision_code":182,"statement_or_summary":68},"MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85","Harris Mfg. Co.","Traditional","SESE",{"k_number":20,"device_name":184,"applicant":185,"decision_date":186,"clearance_type":181,"decision_code":182,"statement_or_summary":68},"SEPCOR TEMPERATURE MONITOR","Separation Science Corp.","1981-12-31",{"k_number":18,"device_name":188,"applicant":189,"decision_date":190,"clearance_type":181,"decision_code":182,"statement_or_summary":68},"HEMOTEMP TM","Marion Laboratories, Inc.","1980-10-10",{"k_number":19,"device_name":192,"applicant":193,"decision_date":194,"clearance_type":181,"decision_code":182,"statement_or_summary":68},"MONITEMP BLOOD PACK TEMP. MONITOR","Liquid Crystal Products, Inc.","1980-04-16",{"items":196,"total":67},[]]