[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-IGN":3},{"classification":4,"mappedDevices":50,"similarCandidates":51,"relatedClassifications":126,"syncDates":289,"translation":296,"marketSummary":302,"recalls":315,"k510s":317,"pmas":328},{"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":15,"raw":16,"created_at":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":47,"event_count":47},1454,"IGN","Fluid, Bouin'S","1","864.4010","PA","Pathology","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":42,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":42,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":42,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"k_number":18,"fei_number":21,"registration_number":38},[19,20],"K822129","K833515",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"3003103936","2244894","3017970519","1831638","3004074729","1419699","3006365273","1219125","2518071","3007496191","1625587","1000122268","3008572203","1640981","3016741564","3008174888",[24,39,25,26,27,28,29,30,40,32,31,41,34,35,36,37],"1125908","2247035","3009432145","N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.949024+00:00",0,null,2,[],[52,60,68,76,83,91,98,105,112,119],{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":47,"vector_similarity":58,"score":59},2324,"空気流動ベッド","Ⅱ","35921000",0.24,0.599717,0.0322665,{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":47,"vector_similarity":66,"score":67},4043,"歯肉溝滲出液測定器","Ⅰ","33203000",0.1875,0.598273,0.0307765,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":47,"vector_similarity":74,"score":75},121,"脳脊髄液用カテーテル","Ⅳ","16133000",0.166667,0.601391,0.0304147,{"medical_device_id":77,"generic_name":78,"class_classification":55,"jmdn_code":79,"name_similarity":80,"definition_similarity":47,"vector_similarity":81,"score":82},2061,"経血用収集器","18132000",0.176471,0.59552,0.0298574,{"medical_device_id":84,"generic_name":85,"class_classification":86,"jmdn_code":87,"name_similarity":88,"definition_similarity":47,"vector_similarity":89,"score":90},441,"ヘパリン使用涙液・涙道シリコーンチューブ","Ⅲ","70337203",0.137931,0.587983,0.0263339,{"medical_device_id":92,"generic_name":93,"class_classification":55,"jmdn_code":94,"name_similarity":95,"definition_similarity":47,"vector_similarity":96,"score":97},2330,"液体用高圧蒸気滅菌器","41450010",0.15,0.582141,0.0258161,{"medical_device_id":99,"generic_name":100,"class_classification":55,"jmdn_code":101,"name_similarity":102,"definition_similarity":47,"vector_similarity":103,"score":104},2207,"血液体液・経腸栄養用注入セット","70398000",0.157895,0.577986,0.0256034,{"medical_device_id":106,"generic_name":107,"class_classification":55,"jmdn_code":108,"name_similarity":109,"definition_similarity":47,"vector_similarity":110,"score":111},2334,"小型液体用高圧蒸気滅菌器","41450020",0.133333,0.587287,0.0255168,{"medical_device_id":113,"generic_name":114,"class_classification":63,"jmdn_code":115,"name_similarity":116,"definition_similarity":47,"vector_similarity":117,"score":118},4430,"液体包帯","33584000",0.115385,0.583773,0.0243938,{"medical_device_id":120,"generic_name":121,"class_classification":71,"jmdn_code":122,"name_similarity":123,"definition_similarity":47,"vector_similarity":124,"score":125},120,"植込み型脳脊髄液リザーバ","15874004",0.12,0.58279,0.0243148,[127,131,135,138,142,146,149,153,156,159,162,166,170,173,177,180,183,186,189,192,195,199,202,205,208,211,214,217,220,223,226,229,232,235,238,241,244,247,250,253,256,259,262,265,268,271,274,277,280,283,286],{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"PPM","General Purpose Reagent",16,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"IFP","Formalin, Neutral Buffered",15,{"product_code":136,"device_name":137,"device_class":8,"k510_count":134},"KEM","Agent, Clearing",{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"KEO","Formulations, Paraffin, All",11,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"KDX","Solution, Decalcifier, Acid Containing",8,{"product_code":147,"device_name":148,"device_class":8,"k510_count":145},"LDZ","Fixative, Alcohol Containing",{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"IGG","Formaldehyde (Formalin, Formol)",7,{"product_code":154,"device_name":155,"device_class":8,"k510_count":152},"JCC","Ph Buffer",{"product_code":157,"device_name":158,"device_class":8,"k510_count":152},"JCE","Solution, Isotonic",{"product_code":160,"device_name":161,"device_class":8,"k510_count":152},"KEQ","Media, Mounting, Water Soluble",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"LEB","Mounting Media",5,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"LDW","Fixative, Acid Containing",4,{"product_code":171,"device_name":172,"device_class":8,"k510_count":169},"LEA","Preservative, Cytological",{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"IGM","Solution, Carnoy'S",3,{"product_code":178,"device_name":179,"device_class":8,"k510_count":176},"KEP","Media, Mounting, Oil Soluble",{"product_code":181,"device_name":182,"device_class":8,"k510_count":49},"IFH","Solution, Zenker'S",{"product_code":184,"device_name":185,"device_class":8,"k510_count":49},"IFQ","Formulations, Mercuric Chloride For Tissue",{"product_code":187,"device_name":188,"device_class":8,"k510_count":49},"IGC","Formalin-Saline",{"product_code":190,"device_name":191,"device_class":8,"k510_count":49},"IGE","Solution, Formalin Ammonium Bromide",{"product_code":193,"device_name":194,"device_class":8,"k510_count":49},"KEL","Adhesive, Albumin-Based",{"product_code":196,"device_name":197,"device_class":8,"k510_count":198},"IER","Polyethylene Glycol (Carbowax)",1,{"product_code":200,"device_name":201,"device_class":8,"k510_count":198},"IFI","Sprays, Synthetic, Smear",{"product_code":203,"device_name":204,"device_class":8,"k510_count":198},"IFT","Glutaraldehyde",{"product_code":206,"device_name":207,"device_class":8,"k510_count":198},"IFZ","Gelatin For Specimen Adhesion",{"product_code":209,"device_name":210,"device_class":8,"k510_count":198},"IGB","Solution, Formalin-Sodium Acetate",{"product_code":212,"device_name":213,"device_class":8,"k510_count":198},"IGF","Solution, Formalin-Alcohol-Acetic Acid",{"product_code":215,"device_name":216,"device_class":8,"k510_count":198},"IJZ","Oil, Clearing",{"product_code":218,"device_name":219,"device_class":8,"k510_count":198},"LDX","Fixative, Metallic Containing",{"product_code":221,"device_name":222,"device_class":8,"k510_count":198},"LDY","Fixative, Formalin-Containing",{"product_code":224,"device_name":225,"device_class":8,"k510_count":47},"HZI","Acid, Osmic",{"product_code":227,"device_name":228,"device_class":8,"k510_count":47},"IAL","Iodine (Tincture)",{"product_code":230,"device_name":231,"device_class":8,"k510_count":47},"IAM","Solution, Lugol'S",{"product_code":233,"device_name":234,"device_class":8,"k510_count":47},"IAT","Syrup, Gum, Apathy'S",{"product_code":236,"device_name":237,"device_class":8,"k510_count":47},"IAW","Collodion",{"product_code":239,"device_name":240,"device_class":8,"k510_count":47},"IAY","Colchicine",{"product_code":242,"device_name":243,"device_class":8,"k510_count":47},"IBB","Phytohemaglutinin M",{"product_code":245,"device_name":246,"device_class":8,"k510_count":47},"IEX","Gelatin",{"product_code":248,"device_name":249,"device_class":8,"k510_count":47},"IEZ","Celloidin",{"product_code":251,"device_name":252,"device_class":8,"k510_count":47},"IFF","Solution, Decalcifier, Electrolytic",{"product_code":254,"device_name":255,"device_class":8,"k510_count":47},"IFJ","Fixative, Richardson Glycol",{"product_code":257,"device_name":258,"device_class":8,"k510_count":47},"IFL","Polyethylene Glycol Preservative",{"product_code":260,"device_name":261,"device_class":8,"k510_count":47},"IFN","Solution, Orth'S",{"product_code":263,"device_name":264,"device_class":8,"k510_count":47},"IFO","Solution, Newcomer'S",{"product_code":266,"device_name":267,"device_class":8,"k510_count":47},"IFS","Solution, Helly",{"product_code":269,"device_name":270,"device_class":8,"k510_count":47},"IFY","Gelatin-Formalin",{"product_code":272,"device_name":273,"device_class":8,"k510_count":47},"IGD","Solution, Formol Calcium",{"product_code":275,"device_name":276,"device_class":8,"k510_count":47},"IGK","Solution, Clarke'S",{"product_code":278,"device_name":279,"device_class":8,"k510_count":47},"JCB","Detergent",{"product_code":281,"device_name":282,"device_class":8,"k510_count":47},"KDY","Agent, Chelating For Decalcification",{"product_code":284,"device_name":285,"device_class":8,"k510_count":47},"KEE","Osmium Tetroxide",{"product_code":287,"device_name":288,"device_class":8,"k510_count":47},"KEF","Paraformaldehyde",{"510k":290,"classification":291,"enforcement":292,"event":293,"pma":294,"warning_letter":295},"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":297,"definition_ja":48,"commentary_ja":298,"model_name":299,"source_hash":300,"reviewed_by":48,"reviewed_at":48,"created_at":301,"updated_at":301},"ブアン氏液","本品は病理組織検体の固定に用いられる試薬であるブアン氏液です。米国ではクラスIに分類されており、規制上のリスクが低い機器として510(k)の届出が免除されています。","claude-sonnet-5","d3886b12ff99c88d601f2f6ac8e722714f5bf1e3461f213f5de00ddb90ad8970","2026-08-24T01:59:49.679032+00:00",{"product_code":6,"summary_ja":303,"stats":304,"stats_hash":313,"model_name":299,"created_at":314,"updated_at":314},"本製品コードは510(k)届出が累計2件、参入企業数は2社となっており、直近5年間の届出はなく、最新の判定は1983年11月です。不具合報告および回収については、いずれも該当するデータが確認されていません。",{"pma":305,"k510":306,"as_of":308,"events":309,"recalls":310,"top_problems":312},{"latest":48,"originals":47,"supplements":47},{"total":49,"last5y":47,"latest":307,"applicants":49},"1983-11-14","2026-08",{"death":47,"other":47,"total":47,"injury":47,"last5y":47,"malfunction":47,"latest_month":48},{"total":47,"last5y":47,"latest":48,"class_i":47,"class_ii":47,"class_iii":47,"top_root_causes":311},[],[],"9cf5418b9c2c5b4d171955dc550f86eabb7f95fa553fb4afd892db13cc6b5ed1","2026-08-24T04:39:50.654259+00:00",{"items":316,"total":47},[],{"items":318,"total":49},[319,324],{"k_number":20,"device_name":320,"applicant":321,"decision_date":307,"clearance_type":322,"decision_code":323,"statement_or_summary":48},"BOUINS SOLUTION","Sigma Chemical Co.","Traditional","SESE",{"k_number":19,"device_name":325,"applicant":326,"decision_date":327,"clearance_type":322,"decision_code":323,"statement_or_summary":48},"VOLU-SOL BOVINS FIXATIVE","Volu Sol Medical Industries","1982-08-05",{"items":329,"total":47},[]]