[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DQF":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":116,"syncDates":120,"translation":127,"marketSummary":133,"recalls":148,"k510s":150,"pmas":166},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":36,"updated_at":37,"recall_count":38,"latest_recall_date":39,"k510_count":40,"pma_count":38,"event_count":41},5414,"DQF","Actuator, Syringe, Injector Type","2","870.1670","CV","Cardiovascular","HO","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":12,"gmp_exempt_flag":33,"third_party_flag":34,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":35},{"k_number":18,"fei_number":22,"registration_number":30},[19,20,21],"K920177","K882723","K880740",[23,24,25,26,27,28,29],"3033589330","3015309643","3002806476","3006950086","3010421104","3002807111","3012536737",[23,24,31,32,26,27,29],"8020616","3005941719","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.366308+00:00",0,null,3,2,[],[44,52,59,67,74,81,88,95,103,110],{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":38,"vector_similarity":50,"score":51},2190,"医薬品ペン型注入器","Ⅱ","70391000",0.318182,0.713913,0.0308349,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":38,"vector_similarity":57,"score":58},1848,"医薬品・ワクチン注入用注射筒","12132000",0.304348,0.714019,0.0307984,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":38,"vector_similarity":65,"score":66},3861,"洗浄剤注入用具","Ⅰ","70463000",0.261905,0.716509,0.030303,{"medical_device_id":68,"generic_name":69,"class_classification":47,"jmdn_code":70,"name_similarity":71,"definition_similarity":38,"vector_similarity":72,"score":73},2197,"単回使用指示薬注入器","31736002",0.27907,0.704702,0.0299107,{"medical_device_id":75,"generic_name":76,"class_classification":62,"jmdn_code":77,"name_similarity":78,"definition_similarity":38,"vector_similarity":79,"score":80},3750,"注射筒・針用アダプタ","35384000",0.25,0.704045,0.0287904,{"medical_device_id":82,"generic_name":83,"class_classification":62,"jmdn_code":84,"name_similarity":85,"definition_similarity":38,"vector_similarity":86,"score":87},3613,"麻酔用注射筒","35387001",0.225,0.724678,0.0287829,{"medical_device_id":89,"generic_name":90,"class_classification":62,"jmdn_code":91,"name_similarity":92,"definition_similarity":38,"vector_similarity":93,"score":94},3620,"ガラス注射筒","70202000",0.358974,0.667627,0.0280214,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":38,"vector_similarity":101,"score":102},326,"脊椎手術用注入器","Ⅳ","70957000",0.238095,0.687939,0.0274178,{"medical_device_id":104,"generic_name":105,"class_classification":47,"jmdn_code":106,"name_similarity":107,"definition_similarity":38,"vector_similarity":108,"score":109},1845,"能動型機器接続麻酔用注射筒","35387002",0.2,0.736332,0.027365,{"medical_device_id":111,"generic_name":112,"class_classification":62,"jmdn_code":113,"name_similarity":78,"definition_similarity":38,"vector_similarity":114,"score":115},4056,"歯科用注入器具","70718000",0.672215,0.0263975,[117],{"product_code":118,"device_name":119,"device_class":8,"k510_count":38},"NKW","Actuator, Syringe, For Injector, Reprocessed",{"510k":121,"classification":122,"enforcement":123,"event":124,"pma":125,"warning_letter":126},"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":128,"definition_ja":39,"commentary_ja":129,"model_name":130,"source_hash":131,"reviewed_by":39,"reviewed_at":39,"created_at":132,"updated_at":132},"注射器型インジェクター用アクチュエータ","本品は米国FDAの規制上、クラスIIに分類される医療機器であり、市販前届出（510(k)）による審査を受けることが求められています。これは、リスクが中程度であり、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る区分に該当することを意味します。","claude-sonnet-5","60f3cb23fc3602da5804b43440ed89d257bbd58b9704e718ef42f22dc3c226d0","2026-08-24T01:47:50.38553+00:00",{"product_code":6,"summary_ja":134,"stats":135,"stats_hash":146,"model_name":130,"created_at":147,"updated_at":147},"本製品コードの510(k)届出は累計約3件で、3社が申請しており、直近5年間の届出はなく、最新の判定は1992年7月となっています。PMAによる承認実績は確認されていません。不具合報告は累計2件で、内訳は傷害1件と不具合（Malfunction）1件であり、死亡報告は0件、直近5年間の報告はなく、最新の報告は2004年2月です。回収については累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":136,"k510":137,"as_of":139,"events":140,"recalls":143,"top_problems":145},{"latest":39,"originals":38,"supplements":38},{"total":40,"last5y":38,"latest":138,"applicants":40},"1992-07-13","2026-08",{"death":38,"other":38,"total":41,"injury":141,"last5y":38,"malfunction":141,"latest_month":142},1,"2004-02",{"total":38,"last5y":38,"latest":39,"class_i":38,"class_ii":38,"class_iii":38,"top_root_causes":144},[],[],"5ac4247305ca7d0f4ad0499ea0e9c99baaadc7d98f0b5466a3ea5ec3bc553a51","2026-08-24T04:12:57.498101+00:00",{"items":149,"total":38},[],{"items":151,"total":40},[152,158,162],{"k_number":19,"device_name":153,"applicant":154,"decision_date":138,"clearance_type":155,"decision_code":156,"statement_or_summary":157},"VERSA-VIAL","Bioteque America, Inc.","Traditional","SESE","Summary",{"k_number":20,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":155,"decision_code":156,"statement_or_summary":39},"ALCON FLUID INJECTOR","Alcon Laboratories","1988-11-08",{"k_number":21,"device_name":163,"applicant":164,"decision_date":165,"clearance_type":155,"decision_code":156,"statement_or_summary":39},"MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE","Spectramed, Inc.","1988-03-22",{"items":167,"total":38},[]]