[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-IFS":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":101,"syncDates":264,"translation":271,"marketSummary":277,"recalls":290,"k510s":292,"pmas":294},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":16,"raw":17,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":24,"event_count":26},1375,"IFS","Solution, Helly","1","864.4010","PA","Pathology","HE","4","",false,true,{"openfda":18,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":12,"gmp_exempt_flag":20,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":21},{},"N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.949024+00:00",0,null,1,[],[29,37,45,53,60,67,74,81,88,94],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},3834,"耳鼻咽喉科用薬液噴霧器","Ⅰ","70453000",0.310345,0.546075,0.0310245,{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},1048,"歯科用う蝕除去液","Ⅲ","38783000",0.25,0.558272,0.0308349,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":24,"vector_similarity":51,"score":52},2379,"心筋保護液用フィルタ","Ⅱ","70525000",0.257143,0.55591,0.0305504,{"medical_device_id":54,"generic_name":55,"class_classification":32,"jmdn_code":56,"name_similarity":57,"definition_similarity":24,"vector_similarity":58,"score":59},3604,"薬液用両刃針","70196000",0.2,0.568315,0.029907,{"medical_device_id":61,"generic_name":62,"class_classification":40,"jmdn_code":63,"name_similarity":64,"definition_similarity":24,"vector_similarity":65,"score":66},464,"薬液注入用ノズル","70388000",0.264706,0.531379,0.0288501,{"medical_device_id":68,"generic_name":69,"class_classification":48,"jmdn_code":70,"name_similarity":71,"definition_similarity":24,"vector_similarity":72,"score":73},2248,"局所管理生理食塩液含有創傷被覆・保護材","37298002",0.183673,0.558061,0.0286935,{"medical_device_id":75,"generic_name":76,"class_classification":48,"jmdn_code":77,"name_similarity":78,"definition_similarity":24,"vector_similarity":79,"score":80},2397,"人工心肺用プライミング溶液フィルタ","36080000",0.203704,0.537737,0.0284045,{"medical_device_id":82,"generic_name":83,"class_classification":48,"jmdn_code":84,"name_similarity":85,"definition_similarity":24,"vector_similarity":86,"score":87},2164,"血液・医薬品用加温器","10447000",0.321429,0.522992,0.0283242,{"medical_device_id":89,"generic_name":90,"class_classification":32,"jmdn_code":91,"name_similarity":57,"definition_similarity":24,"vector_similarity":92,"score":93},3744,"調整用薬液注入コネクタ","70396000",0.524283,0.0258333,{"medical_device_id":95,"generic_name":96,"class_classification":32,"jmdn_code":97,"name_similarity":98,"definition_similarity":24,"vector_similarity":99,"score":100},3696,"採液針","70324000",0.333333,0.503611,0.0163934,[102,106,110,113,117,121,124,128,131,134,137,141,145,148,152,155,159,162,165,168,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258,261],{"product_code":103,"device_name":104,"device_class":8,"k510_count":105},"PPM","General Purpose Reagent",16,{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"IFP","Formalin, Neutral Buffered",15,{"product_code":111,"device_name":112,"device_class":8,"k510_count":109},"KEM","Agent, Clearing",{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"KEO","Formulations, Paraffin, All",11,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"KDX","Solution, Decalcifier, Acid Containing",8,{"product_code":122,"device_name":123,"device_class":8,"k510_count":120},"LDZ","Fixative, Alcohol Containing",{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"IGG","Formaldehyde (Formalin, Formol)",7,{"product_code":129,"device_name":130,"device_class":8,"k510_count":127},"JCC","Ph Buffer",{"product_code":132,"device_name":133,"device_class":8,"k510_count":127},"JCE","Solution, Isotonic",{"product_code":135,"device_name":136,"device_class":8,"k510_count":127},"KEQ","Media, Mounting, Water Soluble",{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"LEB","Mounting Media",5,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"LDW","Fixative, Acid Containing",4,{"product_code":146,"device_name":147,"device_class":8,"k510_count":144},"LEA","Preservative, Cytological",{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"IGM","Solution, Carnoy'S",3,{"product_code":153,"device_name":154,"device_class":8,"k510_count":151},"KEP","Media, Mounting, Oil Soluble",{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"IFH","Solution, Zenker'S",2,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"IFQ","Formulations, Mercuric Chloride For Tissue",{"product_code":163,"device_name":164,"device_class":8,"k510_count":158},"IGC","Formalin-Saline",{"product_code":166,"device_name":167,"device_class":8,"k510_count":158},"IGE","Solution, Formalin Ammonium Bromide",{"product_code":169,"device_name":170,"device_class":8,"k510_count":158},"IGN","Fluid, Bouin'S",{"product_code":172,"device_name":173,"device_class":8,"k510_count":158},"KEL","Adhesive, Albumin-Based",{"product_code":175,"device_name":176,"device_class":8,"k510_count":26},"IER","Polyethylene Glycol (Carbowax)",{"product_code":178,"device_name":179,"device_class":8,"k510_count":26},"IFI","Sprays, Synthetic, Smear",{"product_code":181,"device_name":182,"device_class":8,"k510_count":26},"IFT","Glutaraldehyde",{"product_code":184,"device_name":185,"device_class":8,"k510_count":26},"IFZ","Gelatin For Specimen Adhesion",{"product_code":187,"device_name":188,"device_class":8,"k510_count":26},"IGB","Solution, Formalin-Sodium Acetate",{"product_code":190,"device_name":191,"device_class":8,"k510_count":26},"IGF","Solution, Formalin-Alcohol-Acetic Acid",{"product_code":193,"device_name":194,"device_class":8,"k510_count":26},"IJZ","Oil, Clearing",{"product_code":196,"device_name":197,"device_class":8,"k510_count":26},"LDX","Fixative, Metallic Containing",{"product_code":199,"device_name":200,"device_class":8,"k510_count":26},"LDY","Fixative, Formalin-Containing",{"product_code":202,"device_name":203,"device_class":8,"k510_count":24},"HZI","Acid, Osmic",{"product_code":205,"device_name":206,"device_class":8,"k510_count":24},"IAL","Iodine (Tincture)",{"product_code":208,"device_name":209,"device_class":8,"k510_count":24},"IAM","Solution, Lugol'S",{"product_code":211,"device_name":212,"device_class":8,"k510_count":24},"IAT","Syrup, Gum, Apathy'S",{"product_code":214,"device_name":215,"device_class":8,"k510_count":24},"IAW","Collodion",{"product_code":217,"device_name":218,"device_class":8,"k510_count":24},"IAY","Colchicine",{"product_code":220,"device_name":221,"device_class":8,"k510_count":24},"IBB","Phytohemaglutinin M",{"product_code":223,"device_name":224,"device_class":8,"k510_count":24},"IEX","Gelatin",{"product_code":226,"device_name":227,"device_class":8,"k510_count":24},"IEZ","Celloidin",{"product_code":229,"device_name":230,"device_class":8,"k510_count":24},"IFF","Solution, Decalcifier, Electrolytic",{"product_code":232,"device_name":233,"device_class":8,"k510_count":24},"IFJ","Fixative, Richardson Glycol",{"product_code":235,"device_name":236,"device_class":8,"k510_count":24},"IFL","Polyethylene Glycol Preservative",{"product_code":238,"device_name":239,"device_class":8,"k510_count":24},"IFN","Solution, Orth'S",{"product_code":241,"device_name":242,"device_class":8,"k510_count":24},"IFO","Solution, Newcomer'S",{"product_code":244,"device_name":245,"device_class":8,"k510_count":24},"IFY","Gelatin-Formalin",{"product_code":247,"device_name":248,"device_class":8,"k510_count":24},"IGD","Solution, Formol Calcium",{"product_code":250,"device_name":251,"device_class":8,"k510_count":24},"IGK","Solution, Clarke'S",{"product_code":253,"device_name":254,"device_class":8,"k510_count":24},"JCB","Detergent",{"product_code":256,"device_name":257,"device_class":8,"k510_count":24},"KDY","Agent, Chelating For Decalcification",{"product_code":259,"device_name":260,"device_class":8,"k510_count":24},"KEE","Osmium Tetroxide",{"product_code":262,"device_name":263,"device_class":8,"k510_count":24},"KEF","Paraformaldehyde",{"510k":265,"classification":266,"enforcement":267,"event":268,"pma":269,"warning_letter":270},"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":272,"definition_ja":25,"commentary_ja":273,"model_name":274,"source_hash":275,"reviewed_by":25,"reviewed_at":25,"created_at":276,"updated_at":276},"ヘリー液","本品は病理組織標本の作製に用いられる組織固定用の溶液です。米国ではクラスIに分類され、市販前届出（510(k)）が免除される区分に位置付けられており、比較的リスクが低い体外診断関連用品として扱われています。","claude-sonnet-5","40824f35c243a06a7e84c4eb5dfc85b2dd549a0774d959ba10bf2a14f71e42b6","2026-08-24T01:58:54.742189+00:00",{"product_code":6,"summary_ja":278,"stats":279,"stats_hash":288,"model_name":274,"created_at":289,"updated_at":289},"本製品はクラスIに分類され、510(k)は届出免除の区分となっており、510(k)・PMAともに承認・届出の実績は確認されていません。不具合報告は累計1件のみで、傷害報告が1件、最新の報告月は1994年1月となっています。回収については累計0件で、クラスIを含め該当する回収事例は確認されていません。",{"pma":280,"k510":281,"as_of":282,"events":283,"recalls":285,"top_problems":287},{"latest":25,"originals":24,"supplements":24},{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":24,"other":24,"total":26,"injury":26,"last5y":24,"malfunction":24,"latest_month":284},"1994-01",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":286},[],[],"72dd916c59f4a0bc9530adce2997a30a205e521b545baf58dab4b58dce93cbaa","2026-08-24T04:39:50.654259+00:00",{"items":291,"total":24},[],{"items":293,"total":24},[],{"items":295,"total":24},[]]