[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KOC":3},{"classification":4,"mappedDevices":284,"similarCandidates":285,"relatedClassifications":359,"syncDates":567},{"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":277,"updated_at":278,"recall_count":279,"latest_recall_date":280,"k510_count":281,"pma_count":282,"event_count":283},3808,"KOC","Accessories, Blood Circuit, Hemodialysis","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":274,"product_code":6,"review_panel":10,"gmp_exempt_flag":274,"third_party_flag":274,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":275,"medical_specialty_description":11,"summary_malfunction_reporting":276},{"k_number":18,"fei_number":201,"registration_number":252},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200],"K833503","K822340","K831176","K831376","K833896","K941803","K770475","K201207","K792277","K941851","K852134","K811977","K761078","K770048","K840062","K760639","K770044","K811981","K760640","K894637","K003712","K840859","K830183","K761051","K760633","K823778","K832925","K152953","K843531","K952572","K830231","K010268","K834596","K964041","K830729","K761081","K830021","K831173","K831770","K895882","K121599","K811457","K920671","K831338","K823375","K833308","K771424","K760637","K812498","K071909","K810074","K841124","K823839","K853555","K760665","K823715","K760638","K832666","K911106","K823068","K790381","K935958","K770383","K840845","K913483","K823733","K830905","K823069","K760627","K920614","K790841","K761082","K831175","K790591","K801356","K081740","K823546","K081043","K971860","K760935","K141997","K760994","K912374","K844185","K760629","K941543","K840146","K840654","K913361","K895244","K822338","K801355","K896006","K002372","K760631","K831482","K770691","K770552","K902588","K230514","K833653","K822339","K840937","K910641","K842436","K760626","K972206","K231589","K822738","K770213","K020103","K801354","K831409","K831606","K770382","K831174","K822283","K770046","K823791","K761038","K822225","K925522","K852135","K823707","K844504","K030456","K160749","K821495","K983707","K082758","K832053","K833906","K911315","K810480","K002816","K022536","K822337","K830291","K832103","K141281","K831433","K833905","K831663","K955277","K900306","K760625","K926374","K950282","K911230","K822796","K781050","K822244","K760632","K770524","K822226","K994306","K760042","K833150","K791411","K172238","K822049","K954676","K832894","K840057","K833440","K833252","K770482","K760628","K082719","K823826","K832623","K760630","K843632","K770043","K242479","K770045","K821367","K910321","K924436","K242176","K832252","K925654",[202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251],"3027859369","3008730267","3030446844","3012494290","1625425","3002681132","3002807005","3001236277","3000247873","1625519","3003076831","3002807744","1720929","3005987240","3038195011","3007475226","3001733054","3006755813","3004111573","3008252904","1643817","3002974635","1000117748","3033903155","3043014136","3001451489","3016096143","3035708507","1000203464","3015335038","3014936217","2020550","3003464075","3013557562","1018470","3005578748","1000126788","3002654698","3017636737","1000306431","1527681","3003015552","3002806960","1000132332","1000138417","3043226252","3014638255","3002807721","3018348","3006849754",[202,253,254,204,255,256,205,206,257,210,211,258,214,259,260,216,261,262,219,225,220,221,222,215,263,226,229,228,264,231,265,266,232,267,233,234,268,235,236,237,240,269,270,247,248,250,271,272,251,273],"1424263","1644312","1225714","9611824","3023981687","2032112","8031561","3004202080","8030665","3010202439","9680579","1056186","1932668","3005162618","9616074","8041145","1650907","2029275","9611823","9617473","1649518","N","Y","Ineligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",13,"2019-01-30",182,0,1218,[],[286,294,301,309,316,323,331,338,345,352],{"medical_device_id":287,"generic_name":288,"class_classification":289,"jmdn_code":290,"name_similarity":291,"definition_similarity":282,"vector_similarity":292,"score":293},765,"ヘパリン使用透析用血液回路セット","Ⅲ","34999203",0.344828,0.701558,0.0312805,{"medical_device_id":295,"generic_name":296,"class_classification":289,"jmdn_code":297,"name_similarity":298,"definition_similarity":282,"vector_similarity":299,"score":300},691,"人工腎臓装置","34995000",0.282609,0.705303,0.0310096,{"medical_device_id":302,"generic_name":303,"class_classification":304,"jmdn_code":305,"name_similarity":306,"definition_similarity":282,"vector_similarity":307,"score":308},2382,"透析用血液回路セット","Ⅱ","34999102",0.413043,0.695862,0.0308862,{"medical_device_id":310,"generic_name":311,"class_classification":289,"jmdn_code":312,"name_similarity":313,"definition_similarity":282,"vector_similarity":314,"score":315},429,"閉鎖式血液透析用カテーテル","42452000",0.216667,0.713931,0.0297095,{"medical_device_id":317,"generic_name":318,"class_classification":289,"jmdn_code":319,"name_similarity":320,"definition_similarity":282,"vector_similarity":321,"score":322},428,"植込み型血液透析用カテーテル","37278000",0.193548,0.723997,0.0295513,{"medical_device_id":324,"generic_name":325,"class_classification":326,"jmdn_code":327,"name_similarity":328,"definition_similarity":282,"vector_similarity":329,"score":330},3873,"手術台アクセサリー","Ⅰ","70469000",0.218182,0.691047,0.0287785,{"medical_device_id":332,"generic_name":333,"class_classification":289,"jmdn_code":334,"name_similarity":335,"definition_similarity":282,"vector_similarity":336,"score":337},829,"腹膜灌流用回路及び関連用具セット","70592000",0.219178,0.673917,0.0278638,{"medical_device_id":339,"generic_name":340,"class_classification":289,"jmdn_code":341,"name_similarity":342,"definition_similarity":282,"vector_similarity":343,"score":344},704,"透析用血液循環ユニット","36428000",0.301587,0.664438,0.0277778,{"medical_device_id":346,"generic_name":347,"class_classification":326,"jmdn_code":348,"name_similarity":349,"definition_similarity":282,"vector_similarity":350,"score":351},3941,"腹膜灌流回路用加熱溶融接合装置","70587000",0.254237,0.665382,0.0274328,{"medical_device_id":353,"generic_name":354,"class_classification":289,"jmdn_code":355,"name_similarity":356,"definition_similarity":282,"vector_similarity":357,"score":358},698,"透析装置用血液量検知器","32127000",0.2,0.676461,0.027027,[360,364,368,372,376,380,384,388,392,396,399,402,406,409,413,416,420,423,427,430,433,436,440,443,446,449,453,456,459,462,465,468,472,475,478,481,484,488,491,495,498,501,504,507,510,513,516,519,522,525,528,531,534,537,540,543,546,549,552,555,558,561,564],{"product_code":361,"device_name":362,"device_class":8,"k510_count":363},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":365,"device_name":366,"device_class":8,"k510_count":367},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":369,"device_name":370,"device_class":8,"k510_count":371},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":373,"device_name":374,"device_class":8,"k510_count":375},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":377,"device_name":378,"device_class":8,"k510_count":379},"LIF","Dialyzer Reprocessing System",57,{"product_code":381,"device_name":382,"device_class":8,"k510_count":383},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":385,"device_name":386,"device_class":8,"k510_count":387},"FJG","Dialyzer, Parallel Flow",36,{"product_code":389,"device_name":390,"device_class":8,"k510_count":391},"FIB","Protector, Transducer, Dialysis",35,{"product_code":393,"device_name":394,"device_class":8,"k510_count":395},"FIN","Tank, Holding, Dialysis",18,{"product_code":397,"device_name":398,"device_class":8,"k510_count":395},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":400,"device_name":401,"device_class":8,"k510_count":279},"FIZ","Meter, Conductivity, Non-Remote",{"product_code":403,"device_name":404,"device_class":8,"k510_count":405},"FHS","Dialyzer, Single Coil",12,{"product_code":407,"device_name":408,"device_class":8,"k510_count":405},"FKR","Subsystem, Proportioning",{"product_code":410,"device_name":411,"device_class":8,"k510_count":412},"FIL","System, Dialysate Delivery, Single Pass",8,{"product_code":414,"device_name":415,"device_class":8,"k510_count":412},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":417,"device_name":418,"device_class":8,"k510_count":419},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":421,"device_name":422,"device_class":8,"k510_count":419},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":424,"device_name":425,"device_class":8,"k510_count":426},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":428,"device_name":429,"device_class":12,"k510_count":426},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":431,"device_name":432,"device_class":8,"k510_count":426},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":434,"device_name":435,"device_class":8,"k510_count":426},"MNV","Strip, Dialysate Ph Indicator",{"product_code":437,"device_name":438,"device_class":8,"k510_count":439},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",5,{"product_code":441,"device_name":442,"device_class":8,"k510_count":439},"FJF","Detector, Air Bubble",{"product_code":444,"device_name":445,"device_class":8,"k510_count":439},"FJT","Intracatheter, Dialysis",{"product_code":447,"device_name":448,"device_class":8,"k510_count":439},"FKJ","Filter, Blood, Dialysis",{"product_code":450,"device_name":451,"device_class":8,"k510_count":452},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":454,"device_name":455,"device_class":8,"k510_count":452},"FJD","Detector, Leak, Blood",{"product_code":457,"device_name":458,"device_class":8,"k510_count":452},"FKY","Connector, Tubing, Dialysate",{"product_code":460,"device_name":461,"device_class":8,"k510_count":452},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":463,"device_name":464,"device_class":8,"k510_count":452},"KXM","System Accessories, Extracorporeal",{"product_code":466,"device_name":467,"device_class":8,"k510_count":452},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":469,"device_name":470,"device_class":8,"k510_count":471},"FID","Tubing, Dialysate",3,{"product_code":473,"device_name":474,"device_class":8,"k510_count":471},"FJB","Detector, Dialysate Level",{"product_code":476,"device_name":477,"device_class":8,"k510_count":471},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":479,"device_name":480,"device_class":8,"k510_count":471},"FKI","Set, Dialyzer Holder",{"product_code":482,"device_name":483,"device_class":8,"k510_count":471},"FLA","Monitor, Temperature, Dialysis",{"product_code":485,"device_name":486,"device_class":8,"k510_count":487},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":489,"device_name":490,"device_class":8,"k510_count":487},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":492,"device_name":493,"device_class":8,"k510_count":494},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":496,"device_name":497,"device_class":8,"k510_count":494},"FIW","Alarm, Pillow Pressure",{"product_code":499,"device_name":500,"device_class":8,"k510_count":494},"FJC","Detector, Blood Level",{"product_code":502,"device_name":503,"device_class":8,"k510_count":494},"FKD","Canister, Coil",{"product_code":505,"device_name":506,"device_class":8,"k510_count":494},"FKL","Insert, Pump, Blood",{"product_code":508,"device_name":509,"device_class":8,"k510_count":494},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":511,"device_name":512,"device_class":8,"k510_count":494},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":514,"device_name":515,"device_class":8,"k510_count":494},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":517,"device_name":518,"device_class":12,"k510_count":282},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":520,"device_name":521,"device_class":8,"k510_count":282},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":523,"device_name":524,"device_class":8,"k510_count":282},"FIS","Flowmeter, Dialysate",{"product_code":526,"device_name":527,"device_class":8,"k510_count":282},"FJA","Manometer, Water",{"product_code":529,"device_name":530,"device_class":8,"k510_count":282},"FJJ","Dialyzer, Twin Coil",{"product_code":532,"device_name":533,"device_class":8,"k510_count":282},"FJP","Adaptor, Y",{"product_code":535,"device_name":536,"device_class":12,"k510_count":282},"FKE","Tie, Dialysis",{"product_code":538,"device_name":539,"device_class":12,"k510_count":282},"FKF","Gun, Tie, Dialysis",{"product_code":541,"device_name":542,"device_class":8,"k510_count":282},"FKM","Adaptor, Fistula",{"product_code":544,"device_name":545,"device_class":8,"k510_count":282},"KQR","Detector, Air Or Foam",{"product_code":547,"device_name":548,"device_class":12,"k510_count":282},"MON","System, Hemodialysis, Remote Accessories",{"product_code":550,"device_name":551,"device_class":8,"k510_count":282},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":553,"device_name":554,"device_class":8,"k510_count":282},"PEV","Dialysis Administration Kit",{"product_code":556,"device_name":557,"device_class":8,"k510_count":282},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":559,"device_name":560,"device_class":8,"k510_count":282},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":562,"device_name":563,"device_class":8,"k510_count":282},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":565,"device_name":566,"device_class":8,"k510_count":282},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":568,"classification":569,"enforcement":570,"event":571,"pma":572,"warning_letter":573},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]