[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FKY":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":107,"syncDates":316,"translation":323,"marketSummary":329,"recalls":346,"k510s":348,"pmas":368},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":31},7023,"FKY","Connector, Tubing, Dialysate","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":18},[19,20,21,22],"K991003","K771428","K830002","K862722","N","Y","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-24T02:00:48.366308+00:00",0,null,4,10,[],[34,42,49,57,64,71,78,86,93,100],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":28,"vector_similarity":40,"score":41},2373,"透析器接続具","Ⅱ","70516000",0.533333,0.763546,0.0327869,{"medical_device_id":43,"generic_name":44,"class_classification":37,"jmdn_code":45,"name_similarity":46,"definition_similarity":28,"vector_similarity":47,"score":48},2384,"血液回路用チューブ接続用コネクタ","70545102",0.447368,0.736928,0.0322581,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":28,"vector_similarity":55,"score":56},3746,"輸液用連結管","Ⅰ","70399000",0.3,0.678896,0.0310096,{"medical_device_id":58,"generic_name":59,"class_classification":52,"jmdn_code":60,"name_similarity":61,"definition_similarity":28,"vector_similarity":62,"score":63},3677,"カテーテルコネクタ","32339000",0.285714,0.672722,0.03031,{"medical_device_id":65,"generic_name":66,"class_classification":37,"jmdn_code":67,"name_similarity":68,"definition_similarity":28,"vector_similarity":69,"score":70},2382,"透析用血液回路セット","34999102",0.261905,0.66934,0.0294181,{"medical_device_id":72,"generic_name":73,"class_classification":37,"jmdn_code":74,"name_similarity":75,"definition_similarity":28,"vector_similarity":76,"score":77},2406,"再使用可能な呼吸回路用コネクタ","34838022",0.235294,0.670607,0.0289916,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":28,"vector_similarity":84,"score":85},766,"ヘパリン使用チューブ接続用コネクタ","Ⅲ","70545203",0.341463,0.653964,0.02886,{"medical_device_id":87,"generic_name":88,"class_classification":52,"jmdn_code":89,"name_similarity":90,"definition_similarity":28,"vector_similarity":91,"score":92},3701,"吸引チューブ","16779000",0.210526,0.679383,0.0284455,{"medical_device_id":94,"generic_name":95,"class_classification":52,"jmdn_code":96,"name_similarity":97,"definition_similarity":28,"vector_similarity":98,"score":99},3725,"静脈ライン用コネクタ","17501000",0.227273,0.663467,0.0275875,{"medical_device_id":101,"generic_name":102,"class_classification":37,"jmdn_code":103,"name_similarity":104,"definition_similarity":28,"vector_similarity":105,"score":106},2072,"外シャント用コネクタ","70318000",0.238095,0.653024,0.0273133,[108,112,116,120,124,128,132,136,140,144,148,151,155,159,162,166,169,173,176,180,183,186,189,193,196,199,202,205,208,211,214,217,221,224,227,230,233,237,240,244,247,250,253,256,259,262,265,268,271,274,277,280,283,286,289,292,295,298,301,304,307,310,313],{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"LIF","Dialyzer Reprocessing System",57,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FJG","Dialyzer, Parallel Flow",36,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"FIB","Protector, Transducer, Dialysis",35,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FIN","Tank, Holding, Dialysis",18,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"FHS","Dialyzer, Single Coil",12,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"FKR","Subsystem, Proportioning",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":167,"device_name":168,"device_class":8,"k510_count":165},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":174,"device_name":175,"device_class":8,"k510_count":172},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":181,"device_name":182,"device_class":12,"k510_count":179},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":184,"device_name":185,"device_class":8,"k510_count":179},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":187,"device_name":188,"device_class":8,"k510_count":179},"MNV","Strip, Dialysate Ph Indicator",{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":194,"device_name":195,"device_class":8,"k510_count":192},"FJF","Detector, Air Bubble",{"product_code":197,"device_name":198,"device_class":8,"k510_count":192},"FJT","Intracatheter, Dialysis",{"product_code":200,"device_name":201,"device_class":8,"k510_count":192},"FKJ","Filter, Blood, Dialysis",{"product_code":203,"device_name":204,"device_class":8,"k510_count":30},"FIG","Clamp, Tubing, Blood, Automatic",{"product_code":206,"device_name":207,"device_class":8,"k510_count":30},"FJD","Detector, Leak, Blood",{"product_code":209,"device_name":210,"device_class":8,"k510_count":30},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":212,"device_name":213,"device_class":8,"k510_count":30},"KXM","System Accessories, Extracorporeal",{"product_code":215,"device_name":216,"device_class":8,"k510_count":30},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"FID","Tubing, Dialysate",3,{"product_code":222,"device_name":223,"device_class":8,"k510_count":220},"FJB","Detector, Dialysate Level",{"product_code":225,"device_name":226,"device_class":8,"k510_count":220},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":228,"device_name":229,"device_class":8,"k510_count":220},"FKI","Set, Dialyzer Holder",{"product_code":231,"device_name":232,"device_class":8,"k510_count":220},"FLA","Monitor, Temperature, Dialysis",{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":238,"device_name":239,"device_class":8,"k510_count":236},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":241,"device_name":242,"device_class":8,"k510_count":243},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":245,"device_name":246,"device_class":8,"k510_count":243},"FIW","Alarm, Pillow Pressure",{"product_code":248,"device_name":249,"device_class":8,"k510_count":243},"FJC","Detector, Blood Level",{"product_code":251,"device_name":252,"device_class":8,"k510_count":243},"FKD","Canister, Coil",{"product_code":254,"device_name":255,"device_class":8,"k510_count":243},"FKL","Insert, Pump, Blood",{"product_code":257,"device_name":258,"device_class":8,"k510_count":243},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":260,"device_name":261,"device_class":8,"k510_count":243},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":263,"device_name":264,"device_class":8,"k510_count":243},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":266,"device_name":267,"device_class":12,"k510_count":28},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":269,"device_name":270,"device_class":8,"k510_count":28},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":272,"device_name":273,"device_class":8,"k510_count":28},"FIS","Flowmeter, Dialysate",{"product_code":275,"device_name":276,"device_class":8,"k510_count":28},"FJA","Manometer, Water",{"product_code":278,"device_name":279,"device_class":8,"k510_count":28},"FJJ","Dialyzer, Twin Coil",{"product_code":281,"device_name":282,"device_class":8,"k510_count":28},"FJP","Adaptor, Y",{"product_code":284,"device_name":285,"device_class":12,"k510_count":28},"FKE","Tie, Dialysis",{"product_code":287,"device_name":288,"device_class":12,"k510_count":28},"FKF","Gun, Tie, Dialysis",{"product_code":290,"device_name":291,"device_class":8,"k510_count":28},"FKM","Adaptor, Fistula",{"product_code":293,"device_name":294,"device_class":8,"k510_count":28},"KQR","Detector, Air Or Foam",{"product_code":296,"device_name":297,"device_class":12,"k510_count":28},"MON","System, Hemodialysis, Remote Accessories",{"product_code":299,"device_name":300,"device_class":8,"k510_count":28},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":302,"device_name":303,"device_class":8,"k510_count":28},"PEV","Dialysis Administration Kit",{"product_code":305,"device_name":306,"device_class":8,"k510_count":28},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":308,"device_name":309,"device_class":8,"k510_count":28},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":311,"device_name":312,"device_class":8,"k510_count":28},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":314,"device_name":315,"device_class":8,"k510_count":28},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":317,"classification":318,"enforcement":319,"event":320,"pma":321,"warning_letter":322},"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":324,"definition_ja":29,"commentary_ja":325,"model_name":326,"source_hash":327,"reviewed_by":29,"reviewed_at":29,"created_at":328,"updated_at":328},"透析液チューブ用コネクタ","本品は、透析液を送るチューブ同士またはチューブと機器を接続するために用いられるコネクタです。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められる区分に位置付けられています。","claude-sonnet-5","534fe46fc705f3d6bfe6eab987507490e7b623e4672c29aed460d7eec4ff2f1f","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":330,"stats":331,"stats_hash":344,"model_name":326,"created_at":345,"updated_at":345},"本製品はクラス II の医療機器で、510(k) 区分により審査されています。510(k) の累計届出件数は4件、参入企業数は4社で、直近5年間の新規届出は確認されていません。不具合報告（MDR）は累計約10件で、傷害が6件と大半を占め、死亡報告は0件です。主な問題としては、体液・血液の漏れ（Fluid\u002FBlood Leak）、不適切な手技（Improper or Incorrect Procedure or Method）、誤接続（Misconnection）が挙げられており、回収については累計0件で、クラスIを含め回収事例は確認されていません。",{"pma":332,"k510":333,"as_of":335,"events":336,"recalls":338,"top_problems":340},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":28,"latest":334,"applicants":30},"1999-06-09","2026-08",{"death":28,"other":243,"total":31,"injury":179,"last5y":30,"malfunction":220,"latest_month":337},"2023-08",{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":339},[],[341,342,343],"Fluid\u002FBlood Leak","Improper or Incorrect Procedure or Method","Misconnection","cac6fb35b792f9779cbb904c49d1965a473fb67235f2779ef6dc493e04dc8be6","2026-08-24T04:21:40.396908+00:00",{"items":347,"total":28},[],{"items":349,"total":30},[350,356,360,364],{"k_number":19,"device_name":351,"applicant":352,"decision_date":334,"clearance_type":353,"decision_code":354,"statement_or_summary":355},"PUMP SEGMENT RINSE LINE W\u002F SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W\u002F LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W\u002F SLI","Dayspring Medical, Inc.","Traditional","SESE","Statement",{"k_number":22,"device_name":357,"applicant":358,"decision_date":359,"clearance_type":353,"decision_code":354,"statement_or_summary":29},"TUBING CONNECTOR #10-810-60 100\u002FPKG NON-STERILE","Mercury Enterprises, Inc.","1986-08-11",{"k_number":21,"device_name":361,"applicant":362,"decision_date":363,"clearance_type":353,"decision_code":354,"statement_or_summary":29},"CAPD COLOR-GUARD SYSTEM PREPKIT","Abbott Laboratories","1983-03-11",{"k_number":20,"device_name":365,"applicant":366,"decision_date":367,"clearance_type":353,"decision_code":354,"statement_or_summary":29},"TENCKHOFF PERITONEAL TUBING ADAPT.","Quinton, Inc.","1977-10-18",{"items":369,"total":28},[]]