[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PTW":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":108,"syncDates":153},{"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":22,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":23,"pma_count":23,"event_count":23},5022,"PTW","System, Peritoneal, Automatic Delivery, Exempt","2","876.5630","GU","Gastroenterology, Urology","4","This product code is the class II exempt counterpart of FKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":18,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":18,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":21},{},"","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00",0,null,[],[27,36,44,52,61,70,78,86,93,101],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":33,"vector_similarity":34,"score":35},820,"自動腹膜灌流用装置","Ⅲ","11226000",0.472727,0.161392,0.561066,0.0285886,{"medical_device_id":37,"generic_name":38,"class_classification":30,"jmdn_code":39,"name_similarity":40,"definition_similarity":41,"vector_similarity":42,"score":43},536,"腹膜洗浄キット","12996009",0.206897,0.0902527,0.566511,0.0261717,{"medical_device_id":45,"generic_name":46,"class_classification":30,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},829,"腹膜灌流用回路及び関連用具セット","70592000",0.189873,0.157233,0.569269,0.0260504,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.0361446,0.232323,0.588263,0.0163934,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},2193,"機械式針なし医薬品・ワクチン用注入器","Ⅱ","18069000",0.0185185,0.213457,0.587025,0.016129,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":69},3384,"自動視野計","Ⅰ","16918001",0.28,0.145511,0.438219,{"medical_device_id":79,"generic_name":80,"class_classification":30,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},1185,"前立腺組織用水蒸気デリバリーシステム","71095003",0.27027,0.178125,0.485713,0.015873,{"medical_device_id":87,"generic_name":88,"class_classification":64,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":85},2194,"ガス式針なし医薬品・ワクチン用注入器","42949000",0.0196078,0.214118,0.586948,{"medical_device_id":94,"generic_name":95,"class_classification":64,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},2564,"自動経皮椎間板切除システム","36077000",0.272727,0.155313,0.4849,0.015625,{"medical_device_id":102,"generic_name":103,"class_classification":73,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":100},3822,"単回使用クラスⅠ処置キット","33961001",0.0365854,0.196141,0.58277,[109,113,117,121,125,129,133,137,141,144,147,150],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"KDJ","Set, Administration, For Peritoneal Dialysis, Disposable",113,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"FKX","System, Peritoneal, Automatic Delivery",83,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"FJS","Catheter, Peritoneal, Long-Term Indwelling",48,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"FKO","Catheter, Peritoneal Dialysis, Single Use",16,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"PNG","Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling",15,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"KPF","System, Dialysate Delivery, Semi-Automatic, Peritoneal",13,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"MLW","Warmer, Peritoneal Dialysate",6,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"KPP","Peritoneal Dialysate Filter",3,{"product_code":142,"device_name":143,"device_class":8,"k510_count":23},"PPJ","Peritoneal Dialysis Administration Kit",{"product_code":145,"device_name":146,"device_class":8,"k510_count":23},"PPK","Peritoneal Dialysis Tubing Kit",{"product_code":148,"device_name":149,"device_class":8,"k510_count":23},"PTU","Catheter, Peritoneal, Long-Term Indwelling, Exempt",{"product_code":151,"device_name":152,"device_class":8,"k510_count":23},"PTV","Catheter, Peritoneal Dialysis, Single Use, Exempt",{"510k":154,"classification":155,"enforcement":156,"event":157,"pma":158,"warning_letter":159},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]