[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FJF":3},{"classification":4,"mappedDevices":33,"similarCandidates":34,"relatedClassifications":106,"syncDates":314,"translation":321,"marketSummary":327,"recalls":341,"k510s":343,"pmas":366},{"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":15,"gmp_exempt_flag":14,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":32},4947,"FJF","Detector, Air Bubble","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18},[19,20,21,22,23],"K780582","K770857","K891327","K904992","K781330","N","Y","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.095002+00:00",0,null,5,1,[],[35,43,51,59,66,72,78,85,92,99],{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":29,"vector_similarity":41,"score":42},732,"人工心肺用空気・液体レベル検出器","Ⅲ","35440000",0.291667,0.706479,0.0322665,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":29,"vector_similarity":49,"score":50},2927,"家庭用気泡浴装置","Ⅱ","70984000",0.333333,0.668311,0.031754,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":29,"vector_similarity":57,"score":58},3376,"呼気ガスディテクタ","Ⅰ","70087000",0.257143,0.690568,0.0308349,{"medical_device_id":60,"generic_name":61,"class_classification":38,"jmdn_code":62,"name_similarity":63,"definition_similarity":29,"vector_similarity":64,"score":65},705,"透析用気泡防止ユニット","36437000",0.276596,0.637641,0.0307765,{"medical_device_id":67,"generic_name":68,"class_classification":46,"jmdn_code":69,"name_similarity":56,"definition_similarity":29,"vector_similarity":70,"score":71},2597,"光学式う蝕検出装置","33995020",0.632772,0.03031,{"medical_device_id":73,"generic_name":74,"class_classification":46,"jmdn_code":75,"name_similarity":56,"definition_similarity":29,"vector_similarity":76,"score":77},2598,"電気式う蝕検出装置","33995030",0.631595,0.0298574,{"medical_device_id":79,"generic_name":80,"class_classification":46,"jmdn_code":81,"name_similarity":82,"definition_similarity":29,"vector_similarity":83,"score":84},1420,"胎児超音波心音計","35068000",0.209302,0.677466,0.0293865,{"medical_device_id":86,"generic_name":87,"class_classification":54,"jmdn_code":88,"name_similarity":89,"definition_similarity":29,"vector_similarity":90,"score":91},3678,"食道挿管検出器","36290000",0.214286,0.644766,0.0292735,{"medical_device_id":93,"generic_name":94,"class_classification":54,"jmdn_code":95,"name_similarity":96,"definition_similarity":29,"vector_similarity":97,"score":98},3263,"X線平面検出器","70029000",0.243243,0.630281,0.0289855,{"medical_device_id":100,"generic_name":101,"class_classification":38,"jmdn_code":102,"name_similarity":103,"definition_similarity":29,"vector_similarity":104,"score":105},736,"体外気泡型人工肺","35100000",0.204545,0.602176,0.0261538,[107,111,115,119,123,127,131,135,139,143,147,150,154,158,161,165,168,172,175,179,182,185,188,191,194,197,201,204,207,210,213,216,220,223,226,229,232,236,239,242,245,248,251,254,257,260,263,266,269,272,275,278,281,284,287,290,293,296,299,302,305,308,311],{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"LIF","Dialyzer Reprocessing System",57,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FJG","Dialyzer, Parallel Flow",36,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"FIB","Protector, Transducer, Dialysis",35,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FIN","Tank, Holding, Dialysis",18,{"product_code":148,"device_name":149,"device_class":8,"k510_count":146},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"FHS","Dialyzer, Single Coil",12,{"product_code":159,"device_name":160,"device_class":8,"k510_count":157},"FKR","Subsystem, Proportioning",{"product_code":162,"device_name":163,"device_class":8,"k510_count":164},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":166,"device_name":167,"device_class":8,"k510_count":164},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":180,"device_name":181,"device_class":12,"k510_count":178},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":183,"device_name":184,"device_class":8,"k510_count":178},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":186,"device_name":187,"device_class":8,"k510_count":178},"MNV","Strip, Dialysate Ph Indicator",{"product_code":189,"device_name":190,"device_class":8,"k510_count":31},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",{"product_code":192,"device_name":193,"device_class":8,"k510_count":31},"FJT","Intracatheter, Dialysis",{"product_code":195,"device_name":196,"device_class":8,"k510_count":31},"FKJ","Filter, Blood, Dialysis",{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":202,"device_name":203,"device_class":8,"k510_count":200},"FJD","Detector, Leak, Blood",{"product_code":205,"device_name":206,"device_class":8,"k510_count":200},"FKY","Connector, Tubing, Dialysate",{"product_code":208,"device_name":209,"device_class":8,"k510_count":200},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":211,"device_name":212,"device_class":8,"k510_count":200},"KXM","System Accessories, Extracorporeal",{"product_code":214,"device_name":215,"device_class":8,"k510_count":200},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"FID","Tubing, Dialysate",3,{"product_code":221,"device_name":222,"device_class":8,"k510_count":219},"FJB","Detector, Dialysate Level",{"product_code":224,"device_name":225,"device_class":8,"k510_count":219},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":227,"device_name":228,"device_class":8,"k510_count":219},"FKI","Set, Dialyzer Holder",{"product_code":230,"device_name":231,"device_class":8,"k510_count":219},"FLA","Monitor, Temperature, Dialysis",{"product_code":233,"device_name":234,"device_class":8,"k510_count":235},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":237,"device_name":238,"device_class":8,"k510_count":235},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":240,"device_name":241,"device_class":8,"k510_count":32},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",{"product_code":243,"device_name":244,"device_class":8,"k510_count":32},"FIW","Alarm, Pillow Pressure",{"product_code":246,"device_name":247,"device_class":8,"k510_count":32},"FJC","Detector, Blood Level",{"product_code":249,"device_name":250,"device_class":8,"k510_count":32},"FKD","Canister, Coil",{"product_code":252,"device_name":253,"device_class":8,"k510_count":32},"FKL","Insert, Pump, Blood",{"product_code":255,"device_name":256,"device_class":8,"k510_count":32},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":258,"device_name":259,"device_class":8,"k510_count":32},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":261,"device_name":262,"device_class":8,"k510_count":32},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":264,"device_name":265,"device_class":12,"k510_count":29},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":267,"device_name":268,"device_class":8,"k510_count":29},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":270,"device_name":271,"device_class":8,"k510_count":29},"FIS","Flowmeter, Dialysate",{"product_code":273,"device_name":274,"device_class":8,"k510_count":29},"FJA","Manometer, Water",{"product_code":276,"device_name":277,"device_class":8,"k510_count":29},"FJJ","Dialyzer, Twin Coil",{"product_code":279,"device_name":280,"device_class":8,"k510_count":29},"FJP","Adaptor, Y",{"product_code":282,"device_name":283,"device_class":12,"k510_count":29},"FKE","Tie, Dialysis",{"product_code":285,"device_name":286,"device_class":12,"k510_count":29},"FKF","Gun, Tie, Dialysis",{"product_code":288,"device_name":289,"device_class":8,"k510_count":29},"FKM","Adaptor, Fistula",{"product_code":291,"device_name":292,"device_class":8,"k510_count":29},"KQR","Detector, Air Or Foam",{"product_code":294,"device_name":295,"device_class":12,"k510_count":29},"MON","System, Hemodialysis, Remote Accessories",{"product_code":297,"device_name":298,"device_class":8,"k510_count":29},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":300,"device_name":301,"device_class":8,"k510_count":29},"PEV","Dialysis Administration Kit",{"product_code":303,"device_name":304,"device_class":8,"k510_count":29},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":306,"device_name":307,"device_class":8,"k510_count":29},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":309,"device_name":310,"device_class":8,"k510_count":29},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":312,"device_name":313,"device_class":8,"k510_count":29},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":315,"classification":316,"enforcement":317,"event":318,"pma":319,"warning_letter":320},"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":322,"definition_ja":30,"commentary_ja":323,"model_name":324,"source_hash":325,"reviewed_by":30,"reviewed_at":30,"created_at":326,"updated_at":326},"気泡検出器","本機器は米国FDA規制においてクラスIIに分類されており、市販前届出（510(k)）による審査区分が適用されます。クラスIIは中程度のリスクを有する医療機器を対象とし、特別な管理要件を満たすことで市販前承認（PMA）よりも簡略化された手続きで市場投入が可能となる区分です。","claude-sonnet-5","2ef82019114c9f27cb45d21225442fd874aab27f0187c5144b892275d646f833","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":328,"stats":329,"stats_hash":339,"model_name":324,"created_at":340,"updated_at":340},"本製品コード（Detector, Air Bubble）は、510(k)による届出が累計5件、参入企業数は5社で、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（MDR）は累計1件で、内訳は傷害が1件のみであり、死亡や不具合（Malfunction）の報告は確認されていません。最新の報告は1994年2月となっています。回収（リコール）については累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":330,"k510":331,"as_of":333,"events":334,"recalls":336,"top_problems":338},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":332,"applicants":31},"1991-02-05","2026-08",{"death":29,"other":29,"total":32,"injury":32,"last5y":29,"malfunction":29,"latest_month":335},"1994-02",{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":337},[],[],"5626d49c6db5e29a55954b7e4a2e950888a75d15a48e90f06ebc258858e14201","2026-08-24T04:21:40.396908+00:00",{"items":342,"total":29},[],{"items":344,"total":31},[345,350,354,358,362],{"k_number":22,"device_name":346,"applicant":347,"decision_date":332,"clearance_type":348,"decision_code":349,"statement_or_summary":30},"MINNILERT AIR DETECTOR","Minntech Corp.","Traditional","SESE",{"k_number":21,"device_name":351,"applicant":352,"decision_date":353,"clearance_type":348,"decision_code":349,"statement_or_summary":30},"NICKLE-TITANIUM ORTHODONTIC WIRE","American Orthodontics","1989-05-10",{"k_number":23,"device_name":355,"applicant":356,"decision_date":357,"clearance_type":348,"decision_code":349,"statement_or_summary":30},"BLOOD LEVEL DETECTOR-MODEL 7601","Bd Becton Dickinson Vacutainer Systems Preanalytic","1978-08-31",{"k_number":19,"device_name":359,"applicant":360,"decision_date":361,"clearance_type":348,"decision_code":349,"statement_or_summary":30},"DETECTOR, BUBBLE & FOAM","Hospal Medical Corp.","1978-06-22",{"k_number":20,"device_name":363,"applicant":364,"decision_date":365,"clearance_type":348,"decision_code":349,"statement_or_summary":30},"DIALYSIS MACHINE, CENTRY II","Cobe Laboratories, Inc.","1977-10-04",{"items":367,"total":29},[]]