[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-BXP":3},{"classification":4,"mappedDevices":69,"similarCandidates":70,"relatedClassifications":144,"syncDates":145,"translation":152,"marketSummary":158,"recalls":176,"k510s":178,"pmas":210},{"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":14,"gmp_exempt_flag":14,"raw":15,"created_at":63,"updated_at":64,"recall_count":65,"latest_recall_date":66,"k510_count":67,"pma_count":65,"event_count":68},3685,"BXP","Transducer, Gas Flow","1","868.2885","AN","Anesthesiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":61,"product_code":6,"review_panel":10,"gmp_exempt_flag":61,"third_party_flag":61,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":61,"medical_specialty_description":11,"summary_malfunction_reporting":62},{"k_number":17,"fei_number":25,"registration_number":53},[18,19,20,21,22,23,24],"K770424","K781039","K832678","K800087","K920360","K761260","K936141",[13,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"3002750084","1000352675","3030446844","3018783526","3001104093","1219324","3002673652","3016618143","3029871637","3003256355","3010370454","3023530182","3014541700","1220908","3023272766","3012309966","1000271197","3038259592","3033959233","1000117260","3007307487","3005783425","2183890","1924066","3016734145","3000126629","3011497859",[13,54,28,29,55,30,31,33,56,34,36,38,39,40,41,57,58,43,44,46,59,47,48,49,50,51,60,52],"9611500","9615102","1836161","9617268","9614485","9710567","1722070","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.095002+00:00",0,null,7,5,[],[71,79,86,94,101,108,116,123,130,137],{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":65,"vector_similarity":77,"score":78},3339,"ガスフロートランスデューサ","Ⅰ","31279000",1,0.881729,0.0327869,{"medical_device_id":80,"generic_name":81,"class_classification":74,"jmdn_code":82,"name_similarity":83,"definition_similarity":65,"vector_similarity":84,"score":85},3484,"ガス圧トランスデューサ","31278000",0.517241,0.804478,0.032002,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":65,"vector_similarity":92,"score":93},1582,"ガス差圧トランスデューサ","Ⅱ","31293000",0.357143,0.767575,0.0303658,{"medical_device_id":95,"generic_name":96,"class_classification":89,"jmdn_code":97,"name_similarity":98,"definition_similarity":65,"vector_similarity":99,"score":100},1403,"非留置型血流量トランスデューサ","31657000",0.390244,0.753309,0.0303309,{"medical_device_id":102,"generic_name":103,"class_classification":89,"jmdn_code":104,"name_similarity":105,"definition_similarity":65,"vector_similarity":106,"score":107},2038,"カテーテル先端型流量式トランスデューサ","36040002",0.516129,0.725149,0.0301178,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":65,"vector_similarity":114,"score":115},91,"心臓用カテーテル先端型流量式トランスデューサ","Ⅳ","36040104",0.432432,0.729677,0.0300769,{"medical_device_id":117,"generic_name":118,"class_classification":74,"jmdn_code":119,"name_similarity":120,"definition_similarity":65,"vector_similarity":121,"score":122},3372,"尿流量トランスデューサ","36799000",0.615385,0.703521,0.0296425,{"medical_device_id":124,"generic_name":125,"class_classification":89,"jmdn_code":126,"name_similarity":127,"definition_similarity":65,"vector_similarity":128,"score":129},2386,"トランスデューサ保護フィルタ","70547000",0.333333,0.725853,0.0287904,{"medical_device_id":131,"generic_name":132,"class_classification":89,"jmdn_code":133,"name_similarity":134,"definition_similarity":65,"vector_similarity":135,"score":136},1423,"心音トランスデューサ","33315000",0.34375,0.711593,0.0283702,{"medical_device_id":138,"generic_name":139,"class_classification":89,"jmdn_code":140,"name_similarity":141,"definition_similarity":65,"vector_similarity":142,"score":143},1409,"再使用可能な圧トランスデューサ","14119000",0.289474,0.709363,0.0268565,[],{"510k":146,"classification":147,"enforcement":148,"event":149,"pma":150,"warning_letter":151},"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":153,"definition_ja":66,"commentary_ja":154,"model_name":155,"source_hash":156,"reviewed_by":66,"reviewed_at":66,"created_at":157,"updated_at":157},"ガス流量トランスデューサ","本機器は米国FDAの規制上、クラスIに分類されており、これは相対的にリスクが低い医療機器を意味します。クラスIの機器の多くは市販前届出（510(k)）が免除されており、本機器についても届出免除（510(k) Exempt）とされているため、市販前届出や市販前承認（PMA）といった審査手続きを経ることなく市場に流通させることが可能です。","claude-sonnet-5","1ea3079339d8581434e6717b9be6e73eeac18d3126d229a122ddecbac12eb7be","2026-08-24T01:44:46.715951+00:00",{"product_code":6,"summary_ja":159,"stats":160,"stats_hash":174,"model_name":155,"created_at":175,"updated_at":175},"本製品コードの510(k)累計件数は7件、参入企業数は7社で、最新の判定は1994年3月となっており、直近5年間の届出実績は確認されていません。不具合報告（MDR）は累計約5件で、いずれもMalfunction（不具合）に分類され、死亡・傷害の報告は確認されていません。直近5年間では約2件の報告があり、最新の報告は2025年9月で、主な問題としてCalibration Problem（校正の問題）、Defective Component（部品の不良）、Environmental Compatibility Problem（環境適合性の問題）が挙げられています。回収については累計件数・各クラスとも確認されていません。",{"pma":161,"k510":162,"as_of":164,"events":165,"recalls":168,"top_problems":170},{"latest":66,"originals":65,"supplements":65},{"total":67,"last5y":65,"latest":163,"applicants":67},"1994-03-31","2026-08",{"death":65,"other":65,"total":68,"injury":65,"last5y":166,"malfunction":68,"latest_month":167},2,"2025-09",{"total":65,"last5y":65,"latest":66,"class_i":65,"class_ii":65,"class_iii":65,"top_root_causes":169},[],[171,172,173],"Calibration Problem","Defective Component","Environmental Compatibility Problem","99d659628322a6728a72e10368182f12b087de6501cdf3ef5b3b410c2e9ebfe1","2026-08-24T04:10:52.385113+00:00",{"items":177,"total":65},[],{"items":179,"total":67},[180,186,190,194,198,202,206],{"k_number":24,"device_name":181,"applicant":182,"decision_date":163,"clearance_type":183,"decision_code":184,"statement_or_summary":185},"UNIPOWER RECHARGEABLE BATTERY PACK","Unipower Corp.","Traditional","SESE","Statement",{"k_number":22,"device_name":187,"applicant":188,"decision_date":189,"clearance_type":183,"decision_code":184,"statement_or_summary":185},"TIMOX OXYGEN TIMER","Medical Fittings, Inc.","1992-08-03",{"k_number":20,"device_name":191,"applicant":192,"decision_date":193,"clearance_type":183,"decision_code":184,"statement_or_summary":66},"PHONATORY FUNCTION ANALYZER PS-77","Kells Medical, Inc.","1984-03-07",{"k_number":21,"device_name":195,"applicant":196,"decision_date":197,"clearance_type":183,"decision_code":184,"statement_or_summary":66},"ULTRASONIC FLOWMETER","The Perkin-Elmer Corp.","1980-03-19",{"k_number":19,"device_name":199,"applicant":200,"decision_date":201,"clearance_type":183,"decision_code":184,"statement_or_summary":66},"OXY-ON DIGITAL OXYGEN TIMER","Chambers & Sadler Mfg.","1978-08-31",{"k_number":18,"device_name":203,"applicant":204,"decision_date":205,"clearance_type":183,"decision_code":184,"statement_or_summary":66},"OXYGEN TWMER, MODEL SST","Timeter Instrument Corp.","1977-03-16",{"k_number":23,"device_name":207,"applicant":208,"decision_date":209,"clearance_type":183,"decision_code":184,"statement_or_summary":66},"ARIZONA OXYGEN TIMER DEVICE","The John Bunn Co.","1976-12-16",{"items":211,"total":65},[]]