[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CCM":3},{"classification":4,"mappedDevices":42,"similarCandidates":43,"relatedClassifications":114,"syncDates":115,"translation":122,"marketSummary":128,"recalls":149,"k510s":151,"pmas":196},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":39,"event_count":41},2310,"CCM","Plethysmograph, Pressure","2","868.1750","AN","Anesthesiology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":34,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":29,"registration_number":32},[18,19,20,21,22,23,24,25,26,27,28],"K843846","K893420","K081823","K843851","K791705","K853390","K023796","K772367","K943259","K852088","K852102",[30,31],"1000271197","2183022",[33,31],"9615102","N","Y","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:48.620842+00:00",0,null,11,[],[44,52,59,66,73,80,87,94,100,107],{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":39,"vector_similarity":50,"score":51},1376,"眼底血圧計","Ⅱ","33384000",0.5,0.739443,0.0327869,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":39,"vector_similarity":57,"score":58},1431,"全身プレティスモグラフ","35242000",0.441176,0.736848,0.0322581,{"medical_device_id":60,"generic_name":61,"class_classification":47,"jmdn_code":62,"name_similarity":63,"definition_similarity":39,"vector_similarity":64,"score":65},1428,"局所ボディプレティスモグラフ","13056000",0.428571,0.730703,0.031746,{"medical_device_id":67,"generic_name":68,"class_classification":47,"jmdn_code":69,"name_similarity":70,"definition_similarity":39,"vector_similarity":71,"score":72},3124,"全身プレティスモグラフ用プログラム","35242012",0.347826,0.684538,0.0310096,{"medical_device_id":74,"generic_name":75,"class_classification":47,"jmdn_code":76,"name_similarity":77,"definition_similarity":39,"vector_similarity":78,"score":79},1412,"筋膜内圧力モニタ","70056000",0.230769,0.691513,0.0299107,{"medical_device_id":81,"generic_name":82,"class_classification":47,"jmdn_code":83,"name_similarity":84,"definition_similarity":39,"vector_similarity":85,"score":86},2014,"造影用耐圧チューブ","70269000",0.25,0.627967,0.0261613,{"medical_device_id":88,"generic_name":89,"class_classification":47,"jmdn_code":90,"name_similarity":91,"definition_similarity":39,"vector_similarity":92,"score":93},2021,"圧力モニタリング用チューブセット","35529000",0.209302,0.656162,0.0257124,{"medical_device_id":95,"generic_name":96,"class_classification":47,"jmdn_code":97,"name_similarity":91,"definition_similarity":39,"vector_similarity":98,"score":99},1409,"再使用可能な圧トランスデューサ","14119000",0.648484,0.025679,{"medical_device_id":101,"generic_name":102,"class_classification":47,"jmdn_code":103,"name_similarity":104,"definition_similarity":39,"vector_similarity":105,"score":106},1600,"振せん描画器","14144000",0.222222,0.627878,0.0248097,{"medical_device_id":108,"generic_name":109,"class_classification":47,"jmdn_code":110,"name_similarity":111,"definition_similarity":39,"vector_similarity":112,"score":113},1433,"圧力用増幅器","36748000",0.272727,0.606071,0.0153846,[],{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":40,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":40,"reviewed_at":40,"created_at":127,"updated_at":127},"圧脈波容積計","本機器は米国FDAの規制体系においてクラスIIに分類されており、市販前届出（510(k)）による審査区分の対象です。クラスIIは中程度のリスクを有する医療機器に適用される区分であり、一般的な管理に加えて特別な管理措置が求められますが、市販前承認（PMA）のような厳格な審査ではなく、実質的同等性を示すことで市販が認められる制度です。","claude-sonnet-5","4a7d31a69a9d232cb4658ce7c2bf86724517ecaa45ac3f2e5e9fdcc335bd3497","2026-08-24T01:44:46.715951+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":147,"model_name":125,"created_at":148,"updated_at":148},"510(k)累計は約10件で、参入企業数は8社となっていますが、直近5年の届出実績は確認されていません。不具合報告は累計約10件で、大半がMalfunction（不具合）であり、傷害の報告も2件含まれています。主な問題としては、Explosion（爆発）、Misassembly by Users（ユーザーによる誤組立）、Failure to Deflate（収縮不良）が挙げられています。回収については累計・直近5年ともに件数は確認されていません。",{"pma":131,"k510":132,"as_of":135,"events":136,"recalls":141,"top_problems":143},{"latest":40,"originals":39,"supplements":39},{"total":41,"last5y":39,"latest":133,"applicants":134},"2009-05-18",8,"2026-08",{"death":39,"other":39,"total":41,"injury":137,"last5y":138,"malfunction":139,"latest_month":140},2,3,9,"2026-03",{"total":39,"last5y":39,"latest":40,"class_i":39,"class_ii":39,"class_iii":39,"top_root_causes":142},[],[144,145,146],"Explosion","Misassembly by Users","Failure to Deflate","0df0dcc9219ee4384e26a8b5a301001770a30618c7157b6caa15a0e8bb5a2051","2026-08-24T04:10:52.385113+00:00",{"items":150,"total":39},[],{"items":152,"total":41},[153,159,164,168,172,176,180,183,186,188,192],{"k_number":20,"device_name":154,"applicant":155,"decision_date":133,"clearance_type":156,"decision_code":157,"statement_or_summary":158},"MASTERSCREEN PAED - BABY BODY","Viasys Healthcare GmbH","Traditional","SESE","Summary",{"k_number":24,"device_name":160,"applicant":161,"decision_date":162,"clearance_type":163,"decision_code":157,"statement_or_summary":158},"MS PAED-BABY BODY","Erich Jaeger GmbH","2003-03-03","Special",{"k_number":26,"device_name":165,"applicant":166,"decision_date":167,"clearance_type":156,"decision_code":157,"statement_or_summary":158},"1085 ULTIMATE E PLETHYSMOGRAPH","Medical Graphics Corp.","1995-04-10",{"k_number":19,"device_name":169,"applicant":170,"decision_date":171,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"MASTERLAB PFT AND MASTERLAB BODY BOX","Quinton, Inc.","1989-06-23",{"k_number":23,"device_name":173,"applicant":174,"decision_date":175,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"INFANT BODY TEST","Erich Jaeger, Inc.","1986-02-05",{"k_number":28,"device_name":177,"applicant":178,"decision_date":179,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM","Warren E. Collins, Inc.","1985-07-31",{"k_number":27,"device_name":181,"applicant":166,"decision_date":182,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"SYSTEM 1085 BODY PLETHYSMOGRAPH","1985-07-30",{"k_number":21,"device_name":184,"applicant":174,"decision_date":185,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"BODYSCREEN II","1985-02-14",{"k_number":18,"device_name":187,"applicant":174,"decision_date":185,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"UNIVERSAL-BODYTEST",{"k_number":22,"device_name":189,"applicant":190,"decision_date":191,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"4200 PNEUMATIC MOUTH SHUTTER","Hans Rudolph, Inc.","1979-10-04",{"k_number":25,"device_name":193,"applicant":194,"decision_date":195,"clearance_type":156,"decision_code":157,"statement_or_summary":40},"CHEST BELLOWS, SMALL","Honeywell, Inc.","1978-01-11",{"items":197,"total":39},[]]