[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LEY":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":100,"syncDates":245,"translation":252,"marketSummary":258,"recalls":272,"k510s":274,"pmas":281},{"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":15,"raw":16,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":27},4298,"LEY","Set, Oral Administration","2","876.5980","GU","Gastroenterology, Urology","HO","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":12,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":18},[19],"K760251","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:48.225237+00:00",0,null,1,2,[],[30,38,45,52,59,66,73,80,87,94],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":24,"vector_similarity":36,"score":37},2172,"輸液ポンプ用輸液セット","Ⅱ","35833000",0.527778,0.647661,0.0325225,{"medical_device_id":39,"generic_name":40,"class_classification":33,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},2174,"輸液セット用コントローラ","36244000",0.452381,0.648032,0.0320184,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":42,"definition_similarity":24,"vector_similarity":50,"score":51},445,"麻酔用輸液セット","Ⅲ","70375000",0.627791,0.0300905,{"medical_device_id":53,"generic_name":54,"class_classification":33,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},2176,"自然落下式・ポンプ接続兼用輸液セット","70371000",0.395833,0.639987,0.0298574,{"medical_device_id":60,"generic_name":61,"class_classification":33,"jmdn_code":62,"name_similarity":63,"definition_similarity":24,"vector_similarity":64,"score":65},2171,"頭皮静脈用静脈内投与セット","17825000",0.38,0.638384,0.0294181,{"medical_device_id":67,"generic_name":68,"class_classification":33,"jmdn_code":69,"name_similarity":70,"definition_similarity":24,"vector_similarity":71,"score":72},2178,"造影剤用輸液セット","70373000",0.422222,0.623185,0.0290099,{"medical_device_id":74,"generic_name":75,"class_classification":33,"jmdn_code":76,"name_similarity":77,"definition_similarity":24,"vector_similarity":78,"score":79},2170,"ノンコアリングニードル付静脈内投与セット","17701000",0.339286,0.623975,0.0283702,{"medical_device_id":81,"generic_name":82,"class_classification":33,"jmdn_code":83,"name_similarity":84,"definition_similarity":24,"vector_similarity":85,"score":86},2177,"静脈圧測定機能付輸液セット","70372000",0.279412,0.640959,0.0280428,{"medical_device_id":88,"generic_name":89,"class_classification":33,"jmdn_code":90,"name_similarity":91,"definition_similarity":24,"vector_similarity":92,"score":93},2175,"熱交換機能付静脈内投与セット","41609000",0.316667,0.626891,0.0280063,{"medical_device_id":95,"generic_name":96,"class_classification":33,"jmdn_code":97,"name_similarity":42,"definition_similarity":24,"vector_similarity":98,"score":99},2173,"インスリンポンプ用輸液セット","35838000",0.601849,0.027109,[101,105,109,113,117,121,125,129,133,136,140,144,148,151,154,157,160,163,166,169,172,175,178,181,184,187,190,193,196,199,202,205,208,211,214,217,220,223,226,229,232,235,238,241],{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"KNT","Tubes, Gastrointestinal (And Accessories)",650,{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"FPD","Tube, Feeding",59,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"PIF","Gastrointestinal Tubes With Enteral Specific Connectors",50,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"PNR","Enteral Syringes With Enteral Specific Connectors",34,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"KGC","Tube, Gastro-Enterostomy",26,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"KDH","Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration",23,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"EYN","Tray, Irrigation, Sterile",15,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"BSS","Tube, Nasogastric",13,{"product_code":134,"device_name":135,"device_class":8,"k510_count":132},"FEG","Tube, Double Lumen For Intestinal Decompression And\u002FOr Intubation",{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"PIO","Enteral Specific Transition Connectors",9,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"FGD","Catheter, Retention, Barium Enema With Bag",6,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"EZK","Catheter, Retention Type",3,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"FRQ","Tube, Levine",{"product_code":152,"device_name":153,"device_class":8,"k510_count":147},"GBT","Catheter, Rectal",{"product_code":155,"device_name":156,"device_class":8,"k510_count":147},"PID","Esophageal Dilator Balloon With Or Without Electrode Sensors",{"product_code":158,"device_name":159,"device_class":8,"k510_count":27},"PBP","Rectal Insert",{"product_code":161,"device_name":162,"device_class":8,"k510_count":27},"PIE","Esophageal Dilator With Balloon And Electrode Sensors",{"product_code":164,"device_name":165,"device_class":8,"k510_count":26},"FEF","Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And \u002F Or Decompression",{"product_code":167,"device_name":168,"device_class":8,"k510_count":26},"FHT","Set, Gavage, Infant, Sterile",{"product_code":170,"device_name":171,"device_class":8,"k510_count":26},"NGU","Balloon, Liver Tamponade",{"product_code":173,"device_name":174,"device_class":8,"k510_count":26},"PLI","Gastrointestional Tube Holder",{"product_code":176,"device_name":177,"device_class":8,"k510_count":24},"FCB","Bag, Hemostatic",{"product_code":179,"device_name":180,"device_class":8,"k510_count":24},"FFW","String And Tubes, Gastrointestinal, To Locate Internal Bleeding",{"product_code":182,"device_name":183,"device_class":8,"k510_count":24},"LCG","Intestinal Splinting Tubes",{"product_code":185,"device_name":186,"device_class":8,"k510_count":24},"PRM","Enteral Administration Kit (Adult & Pediatric)",{"product_code":188,"device_name":189,"device_class":8,"k510_count":24},"PRP","Balloon Gastrostomy Tube Kit",{"product_code":191,"device_name":192,"device_class":8,"k510_count":24},"PRR","Feeding Tube Kit",{"product_code":194,"device_name":195,"device_class":8,"k510_count":24},"PRS","Gastric Colonic Catheter Irrigation Kit",{"product_code":197,"device_name":198,"device_class":8,"k510_count":24},"PRT","Gastric Irrigation And Aspiration Kit",{"product_code":200,"device_name":201,"device_class":8,"k510_count":24},"PRW","Gastrointestinal Tube Kit",{"product_code":203,"device_name":204,"device_class":8,"k510_count":24},"PRX","Gastrostomy Guide Wire Placement Kit",{"product_code":206,"device_name":207,"device_class":8,"k510_count":24},"PRY","Gastrostomy Jejunostomy Feeding Tube Kit",{"product_code":209,"device_name":210,"device_class":8,"k510_count":24},"PRZ","Gastrostomy Tube Kit",{"product_code":212,"device_name":213,"device_class":8,"k510_count":24},"PSA","Laparoscopic Jejunostomy Kit",{"product_code":215,"device_name":216,"device_class":8,"k510_count":24},"PSB","Nasogastric Feed Tube Kit",{"product_code":218,"device_name":219,"device_class":8,"k510_count":24},"PSC","Nasogastric-Gastrojejunal Kit",{"product_code":221,"device_name":222,"device_class":8,"k510_count":24},"PSD","Laparoscopic Gastrostomy Kit",{"product_code":224,"device_name":225,"device_class":8,"k510_count":24},"PSE","Needle Catheter Jejunostomy Kit",{"product_code":227,"device_name":228,"device_class":8,"k510_count":24},"PSF","Non-Balloon Replacement Gastrostomy System",{"product_code":230,"device_name":231,"device_class":8,"k510_count":24},"PSG","Percutaneous Endoscopic Gastrostomy Kit",{"product_code":233,"device_name":234,"device_class":8,"k510_count":24},"PSH","Percutaneous Replacement Gastrostomy Tube Kit",{"product_code":236,"device_name":237,"device_class":8,"k510_count":24},"PSI","Perineal Irrigation Kit",{"product_code":239,"device_name":240,"device_class":8,"k510_count":24},"PSK","Replacement Gastrostomy Feeding Catheter Tray",{"product_code":242,"device_name":243,"device_class":244,"k510_count":24},"PTK","Pediatric Esophageal Atresia Anastomosis Device","3",{"510k":246,"classification":247,"enforcement":248,"event":249,"pma":250,"warning_letter":251},"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":253,"definition_ja":25,"commentary_ja":254,"model_name":255,"source_hash":256,"reviewed_by":25,"reviewed_at":25,"created_at":257,"updated_at":257},"経口投与セット","この機器は米国のデバイスクラス分類ではクラスIIに該当し、市販前届出である510(k)の対象となる医療機器です。510(k)は既存の同等品との実質的同等性を示すことで市販が認められる審査区分であり、クラスIIIに適用される市販前承認（PMA）と比べて相対的にリスクが低い機器に適用されます。","claude-sonnet-5","d7b0265e7401f47d215839c4d8fcce65d05a2ac8bee14500400c14ced7b78331","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":259,"stats":260,"stats_hash":270,"model_name":255,"created_at":271,"updated_at":271},"510(k)の累計件数は1件で、参入企業数は1社にとどまり、直近5年間の届出実績は確認されていません。不具合報告は累計2件で、傷害が1件、不具合（Malfunction）が1件となっており、直近5年間の報告は確認されていません。回収についてはクラスI・II・IIIのいずれも報告がなく、累計件数は0件です。",{"pma":261,"k510":262,"as_of":264,"events":265,"recalls":267,"top_problems":269},{"latest":25,"originals":24,"supplements":24},{"total":26,"last5y":24,"latest":263,"applicants":26},"1976-09-15","2026-08",{"death":24,"other":24,"total":27,"injury":26,"last5y":24,"malfunction":26,"latest_month":266},"1995-12",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":268},[],[],"9c6b63994dfe6f7f5f310af16bd50bf0885f1c1312a43ed9eefb24f5bf7f9382","2026-08-24T04:49:04.081036+00:00",{"items":273,"total":24},[],{"items":275,"total":26},[276],{"k_number":19,"device_name":277,"applicant":278,"decision_date":263,"clearance_type":279,"decision_code":280,"statement_or_summary":25},"SET, ORAL ADMINISTRATION","Cis Radiopharmaceuticals, Inc.","Traditional","SESE",{"items":282,"total":24},[]]