[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FJD":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":110,"syncDates":319,"translation":326,"marketSummary":332,"recalls":350,"k510s":352,"pmas":371},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},980,"FJD","Detector, Leak, Blood","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":18,"fei_number":23,"registration_number":26},[19,20,21,22],"K123805","K042322","K990206","K012115",[24,25],"1833387","1000125241",[24,27],"2028411","N","Y","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:47.513022+00:00",0,null,4,11,[],[39,47,54,62,69,75,82,89,96,103],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},699,"透析装置用血液漏出検知器","Ⅲ","32128000",0.526316,0.750364,0.0327869,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":33,"vector_similarity":52,"score":53},698,"透析装置用血液量検知器","32127000",0.404762,0.676504,0.0322581,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":33,"vector_similarity":60,"score":61},2598,"電気式う蝕検出装置","Ⅱ","33995030",0.257143,0.634953,0.0285773,{"medical_device_id":63,"generic_name":64,"class_classification":57,"jmdn_code":65,"name_similarity":66,"definition_similarity":33,"vector_similarity":67,"score":68},1285,"核医学装置用手持型検出器","40646000",0.222222,0.639931,0.0274798,{"medical_device_id":70,"generic_name":71,"class_classification":57,"jmdn_code":72,"name_similarity":66,"definition_similarity":33,"vector_similarity":73,"score":74},2163,"血液フィルタ","35071000",0.634159,0.0266714,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":59,"definition_similarity":33,"vector_similarity":80,"score":81},3376,"呼気ガスディテクタ","Ⅰ","70087000",0.628339,0.0265845,{"medical_device_id":83,"generic_name":84,"class_classification":57,"jmdn_code":85,"name_similarity":86,"definition_similarity":33,"vector_similarity":87,"score":88},2355,"血液用冷蔵庫","35486000",0.258065,0.621276,0.0261613,{"medical_device_id":90,"generic_name":91,"class_classification":42,"jmdn_code":92,"name_similarity":93,"definition_similarity":33,"vector_similarity":94,"score":95},697,"透析装置用透析液量検知器","32126000",0.234043,0.622485,0.024697,{"medical_device_id":97,"generic_name":98,"class_classification":57,"jmdn_code":99,"name_similarity":100,"definition_similarity":33,"vector_similarity":101,"score":102},1420,"胎児超音波心音計","35068000",0.209302,0.624023,0.023823,{"medical_device_id":104,"generic_name":105,"class_classification":57,"jmdn_code":106,"name_similarity":107,"definition_similarity":33,"vector_similarity":108,"score":109},1443,"ヒス束検出器","12009000",0.333333,0.597565,0.015873,[111,115,119,123,127,131,135,139,143,147,151,154,158,162,165,169,172,176,179,183,186,189,192,196,199,202,205,208,211,214,217,220,224,227,230,233,236,240,243,247,250,253,256,259,262,265,268,271,274,277,280,283,286,289,292,295,298,301,304,307,310,313,316],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"LIF","Dialyzer Reprocessing System",57,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"FJG","Dialyzer, Parallel Flow",36,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"FIB","Protector, Transducer, Dialysis",35,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"FIN","Tank, Holding, Dialysis",18,{"product_code":152,"device_name":153,"device_class":8,"k510_count":150},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"FHS","Dialyzer, Single Coil",12,{"product_code":163,"device_name":164,"device_class":8,"k510_count":161},"FKR","Subsystem, Proportioning",{"product_code":166,"device_name":167,"device_class":8,"k510_count":168},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":170,"device_name":171,"device_class":8,"k510_count":168},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":177,"device_name":178,"device_class":8,"k510_count":175},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":180,"device_name":181,"device_class":8,"k510_count":182},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":184,"device_name":185,"device_class":12,"k510_count":182},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":187,"device_name":188,"device_class":8,"k510_count":182},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":190,"device_name":191,"device_class":8,"k510_count":182},"MNV","Strip, Dialysate Ph Indicator",{"product_code":193,"device_name":194,"device_class":8,"k510_count":195},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":197,"device_name":198,"device_class":8,"k510_count":195},"FJF","Detector, Air Bubble",{"product_code":200,"device_name":201,"device_class":8,"k510_count":195},"FJT","Intracatheter, Dialysis",{"product_code":203,"device_name":204,"device_class":8,"k510_count":195},"FKJ","Filter, Blood, Dialysis",{"product_code":206,"device_name":207,"device_class":8,"k510_count":35},"FIG","Clamp, Tubing, Blood, Automatic",{"product_code":209,"device_name":210,"device_class":8,"k510_count":35},"FKY","Connector, Tubing, Dialysate",{"product_code":212,"device_name":213,"device_class":8,"k510_count":35},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":215,"device_name":216,"device_class":8,"k510_count":35},"KXM","System Accessories, Extracorporeal",{"product_code":218,"device_name":219,"device_class":8,"k510_count":35},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":221,"device_name":222,"device_class":8,"k510_count":223},"FID","Tubing, Dialysate",3,{"product_code":225,"device_name":226,"device_class":8,"k510_count":223},"FJB","Detector, Dialysate Level",{"product_code":228,"device_name":229,"device_class":8,"k510_count":223},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":231,"device_name":232,"device_class":8,"k510_count":223},"FKI","Set, Dialyzer Holder",{"product_code":234,"device_name":235,"device_class":8,"k510_count":223},"FLA","Monitor, Temperature, Dialysis",{"product_code":237,"device_name":238,"device_class":8,"k510_count":239},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":241,"device_name":242,"device_class":8,"k510_count":239},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":244,"device_name":245,"device_class":8,"k510_count":246},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":248,"device_name":249,"device_class":8,"k510_count":246},"FIW","Alarm, Pillow Pressure",{"product_code":251,"device_name":252,"device_class":8,"k510_count":246},"FJC","Detector, Blood Level",{"product_code":254,"device_name":255,"device_class":8,"k510_count":246},"FKD","Canister, Coil",{"product_code":257,"device_name":258,"device_class":8,"k510_count":246},"FKL","Insert, Pump, Blood",{"product_code":260,"device_name":261,"device_class":8,"k510_count":246},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":263,"device_name":264,"device_class":8,"k510_count":246},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":266,"device_name":267,"device_class":8,"k510_count":246},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":269,"device_name":270,"device_class":12,"k510_count":33},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":272,"device_name":273,"device_class":8,"k510_count":33},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":275,"device_name":276,"device_class":8,"k510_count":33},"FIS","Flowmeter, Dialysate",{"product_code":278,"device_name":279,"device_class":8,"k510_count":33},"FJA","Manometer, Water",{"product_code":281,"device_name":282,"device_class":8,"k510_count":33},"FJJ","Dialyzer, Twin Coil",{"product_code":284,"device_name":285,"device_class":8,"k510_count":33},"FJP","Adaptor, Y",{"product_code":287,"device_name":288,"device_class":12,"k510_count":33},"FKE","Tie, Dialysis",{"product_code":290,"device_name":291,"device_class":12,"k510_count":33},"FKF","Gun, Tie, Dialysis",{"product_code":293,"device_name":294,"device_class":8,"k510_count":33},"FKM","Adaptor, Fistula",{"product_code":296,"device_name":297,"device_class":8,"k510_count":33},"KQR","Detector, Air Or Foam",{"product_code":299,"device_name":300,"device_class":12,"k510_count":33},"MON","System, Hemodialysis, Remote Accessories",{"product_code":302,"device_name":303,"device_class":8,"k510_count":33},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":305,"device_name":306,"device_class":8,"k510_count":33},"PEV","Dialysis Administration Kit",{"product_code":308,"device_name":309,"device_class":8,"k510_count":33},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":311,"device_name":312,"device_class":8,"k510_count":33},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":314,"device_name":315,"device_class":8,"k510_count":33},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":317,"device_name":318,"device_class":8,"k510_count":33},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":320,"classification":321,"enforcement":322,"event":323,"pma":324,"warning_letter":325},"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":327,"definition_ja":34,"commentary_ja":328,"model_name":329,"source_hash":330,"reviewed_by":34,"reviewed_at":34,"created_at":331,"updated_at":331},"血液漏検出器","この機器は、米国FDAの規制上クラスIIに分類される医療機器です。クラスIIの機器は一般的に、市販前届出（510(k)）による審査を経て、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ます。","claude-sonnet-5","9aa90c03f16a1db048768200da612e0029664a6b6e3a290c7ea823b6ee847f3d","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":333,"stats":334,"stats_hash":348,"model_name":329,"created_at":349,"updated_at":349},"510(k)の累計件数は4件、参入企業数は3社ですが、直近5年の届出は確認されていません。不具合報告は累計約10件で、死亡報告はなく、傷害が1件含まれています。主な問題としてはFluid\u002FBlood Leak（体液・血液漏れ）、Output Problem（出力の問題）、Pressure Problem（圧力の問題）が挙げられています。回収については累計件数0件で、該当する事例は確認されていません。",{"pma":335,"k510":336,"as_of":338,"events":339,"recalls":342,"top_problems":344},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":337,"applicants":223},"2013-03-20","2026-08",{"death":33,"other":340,"total":36,"injury":246,"last5y":239,"malfunction":246,"latest_month":341},9,"2025-09",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":343},[],[345,346,347],"Fluid\u002FBlood Leak","Output Problem","Pressure Problem","299391a043150abaa1740f1b8d7007f719600ba7a973577f05dc4acd269932ee","2026-08-24T04:21:40.396908+00:00",{"items":351,"total":33},[],{"items":353,"total":35},[354,360,364,368],{"k_number":19,"device_name":355,"applicant":356,"decision_date":337,"clearance_type":357,"decision_code":358,"statement_or_summary":359},"E-Z CHEK BLOOD LEAK TEST STRIPS","Reprocessing Products Corp","Traditional","SESE","Summary",{"k_number":20,"device_name":361,"applicant":362,"decision_date":363,"clearance_type":357,"decision_code":358,"statement_or_summary":359},"STERICHEK BLOOD LEAK REAGENT STRIPS","Hach Company","2004-12-07",{"k_number":22,"device_name":365,"applicant":366,"decision_date":367,"clearance_type":357,"decision_code":358,"statement_or_summary":359},"SERIM BLOOD LEAK TEST STRIP-2","Serim Research Corp.","2001-11-30",{"k_number":21,"device_name":369,"applicant":366,"decision_date":370,"clearance_type":357,"decision_code":358,"statement_or_summary":359},"SERIM BLOOD LEAK TEST STRIP","1999-04-21",{"items":372,"total":33},[]]