[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LHD":3},{"classification":4,"mappedDevices":83,"similarCandidates":84,"relatedClassifications":153,"syncDates":154,"translation":161,"marketSummary":167,"recalls":187,"k510s":189,"pmas":271},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":77,"updated_at":78,"recall_count":79,"latest_recall_date":80,"k510_count":81,"pma_count":79,"event_count":82},6533,"LHD","Device, Fertility Diagnostic, Proceptive","U","","Unknown","OB","7",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":74,"product_code":6,"review_panel":11,"gmp_exempt_flag":74,"third_party_flag":74,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":75,"life_sustain_support_flag":74,"medical_specialty_description":10,"summary_malfunction_reporting":76},{"k_number":16,"fei_number":41,"registration_number":71},[17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"K852801","K122337","K050094","K813497","K904211","K844043","K021978","K823463","K952756","K901512","K030961","K945427","K843699","K810832","K870999","K880618","K870528","K821507","K102499","K852194","K002726","K200163","K845009","K823209",[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],"3030648160","3005321947","3001585609","3017415521","3003993690","3009238284","3012725363","3045953291","3008517993","3013501873","3014848805","3003010579","3013587414","3015599655","3016867013","3020773178","2434008","3006799946","3011197658","2110898","3016866092","3009307663","3012316249","3016099071","3020161798","3003079707","3014343954","3012228195","3033531398",[42,43,44,45,72,46,47,48,49,50,51,52,54,55,56,57,58,59,60,73,61,62,63,64,65,66,68,69,70],"8020605","9680225","N","1","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:47.318533+00:00",0,null,24,6,[],[85,93,101,109,114,121,128,135,140,147],{"medical_device_id":86,"generic_name":87,"class_classification":88,"jmdn_code":89,"name_similarity":90,"definition_similarity":79,"vector_similarity":91,"score":92},1060,"子宮内避妊用具","Ⅲ","35125000",0.224138,0.646115,0.0280833,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":79,"vector_similarity":99,"score":100},264,"医薬品投与用植込み型避妊具","Ⅳ","35945000",0.191176,0.648955,0.0256536,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":79,"vector_similarity":107,"score":108},1586,"診断用気道陽圧ユニット","Ⅱ","37235000",0.258065,0.486126,0.0163934,{"medical_device_id":110,"generic_name":111,"class_classification":104,"jmdn_code":112,"name_similarity":79,"definition_similarity":79,"vector_similarity":113,"score":108},2910,"隅角鏡","11894000",0.686767,{"medical_device_id":115,"generic_name":116,"class_classification":88,"jmdn_code":117,"name_similarity":118,"definition_similarity":79,"vector_similarity":119,"score":120},672,"卵管用チューブ補綴材","35264000",0.0847458,0.678533,0.016129,{"medical_device_id":122,"generic_name":123,"class_classification":124,"jmdn_code":125,"name_similarity":126,"definition_similarity":79,"vector_similarity":127,"score":120},3275,"画像診断用イメージャ","Ⅰ","70036000",0.244444,0.576065,{"medical_device_id":129,"generic_name":130,"class_classification":104,"jmdn_code":131,"name_similarity":132,"definition_similarity":79,"vector_similarity":133,"score":134},3180,"病理ホールスライド画像診断補助装置","15132012",0.2375,0.612988,0.015873,{"medical_device_id":136,"generic_name":137,"class_classification":124,"jmdn_code":138,"name_similarity":79,"definition_similarity":79,"vector_similarity":139,"score":134},3590,"精子・精液分析装置","36744000",0.67499,{"medical_device_id":141,"generic_name":142,"class_classification":88,"jmdn_code":143,"name_similarity":144,"definition_similarity":79,"vector_similarity":145,"score":146},658,"輸精管用補綴材","31995003",0.127273,0.666862,0.015625,{"medical_device_id":148,"generic_name":149,"class_classification":124,"jmdn_code":150,"name_similarity":151,"definition_similarity":79,"vector_similarity":152,"score":146},3280,"四肢画像診断・放射線治療用患者体位固定具","40900000",0.233333,0.609784,[],{"510k":155,"classification":156,"enforcement":157,"event":158,"pma":159,"warning_letter":160},"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":162,"definition_ja":80,"commentary_ja":163,"model_name":164,"source_hash":165,"reviewed_by":80,"reviewed_at":80,"created_at":166,"updated_at":166},"妊孕性予知診断装置","本品は、女性の妊孕期（妊娠しやすい時期）を予知的に判定するために用いられる不妊関連の診断機器です。米国ではデバイスクラスが未分類（Unclassified）とされており、正式なクラス分類が定まっていないものの、FDAは取締裁量（Enforcement Discretion）の方針により、市販前届出（510(k)）や市販前承認（PMA）といった通常の審査プロセスを適用せずに規制上の対応を行っています。","claude-sonnet-5","0a55ca648d35de83957c207982dc8739749bf90998ff3fe2efdf87af0f2d3399","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":168,"stats":169,"stats_hash":185,"model_name":164,"created_at":186,"updated_at":186},"510(k)は累計約20件、参入企業数は約20社に上りますが、直近5年間の届出はなく、最新の判定も2021年1月となっています。不具合報告は累計6件で、Malfunction（不具合）が4件、Injury（傷害）が2件を占め、主な問題としてDevice Fell（機器の落下）、Device Markings\u002FLabelling Problem（表示・ラベル問題）、Device Slipped（機器の滑り）が挙げられています。回収については累計0件で、確認されていません。",{"pma":170,"k510":171,"as_of":174,"events":175,"recalls":179,"top_problems":181},{"latest":80,"originals":79,"supplements":79},{"total":81,"last5y":79,"latest":172,"applicants":173},"2021-01-19",21,"2026-08",{"death":79,"other":79,"total":82,"injury":176,"last5y":176,"malfunction":177,"latest_month":178},2,4,"2023-05",{"total":79,"last5y":79,"latest":80,"class_i":79,"class_ii":79,"class_iii":79,"top_root_causes":180},[],[182,183,184],"Device Fell","Device Markings\u002FLabelling Problem","Device Slipped","f5133635b92d88950c55f78df432f0ee5fb52e7beec620c884d70d515cc46320","2026-08-24T04:50:56.354429+00:00",{"items":188,"total":79},[],{"items":190,"total":81},[191,197,201,205,209,213,217,221,225,229,233,236,240,244,248,252,256,260,264,267],{"k_number":38,"device_name":192,"applicant":193,"decision_date":172,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"Ava Fertility Tracker","Ava AG","Traditional","SESE","Summary",{"k_number":18,"device_name":198,"applicant":199,"decision_date":200,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"OVUSENSE","Fertility Focus, Ltd.","2013-08-06",{"k_number":35,"device_name":202,"applicant":203,"decision_date":204,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"DUOFERTILITY","Cambridge Temperature Concepts , Ltd.","2011-12-20",{"k_number":19,"device_name":206,"applicant":207,"decision_date":208,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"LADY COMP USA","Lady Comp USA","2006-04-20",{"k_number":27,"device_name":210,"applicant":211,"decision_date":212,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921","Microlife Corp.","2003-09-12",{"k_number":23,"device_name":214,"applicant":215,"decision_date":216,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"PETIT SOPHIA","Nishitomo Co., Inc.","2003-04-08",{"k_number":37,"device_name":218,"applicant":219,"decision_date":220,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"TCOYF FERTILITY SOFTWARE VERSION 1.0","Ovusoft, LLC","2001-04-06",{"k_number":25,"device_name":222,"applicant":223,"decision_date":224,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"MEDI-AID BASAL THERMOMETER","Polymedica Industries, Inc.","1995-09-25",{"k_number":28,"device_name":226,"applicant":227,"decision_date":228,"clearance_type":194,"decision_code":195,"statement_or_summary":196},"B-D DIGITAL THERMOMETER","Bd Becton Dickinson Vacutainer Systems Preanalytic","1995-06-15",{"k_number":21,"device_name":230,"applicant":231,"decision_date":232,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"BIOSELF 2000 FERTILITY INDICATOR","Bioself, Inc.","1992-10-14",{"k_number":26,"device_name":234,"applicant":215,"decision_date":235,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"L SOPHIA","1990-07-20",{"k_number":32,"device_name":237,"applicant":238,"decision_date":239,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"FERTILITY FORECASTER COMPUTER PROGRAM","Fertile Time, Ltd.","1988-06-24",{"k_number":31,"device_name":241,"applicant":242,"decision_date":243,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"GENDER CHOICE INFORMATION KIT, FEMALE AND MALE","Procare C\u002FO Wiley, Rein & Fielding","1987-07-14",{"k_number":33,"device_name":245,"applicant":246,"decision_date":247,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"OVU-TRAC OVULATION TIMING KIT","Ob\u002FGyn Concepts, Ltd.","1987-05-06",{"k_number":36,"device_name":249,"applicant":250,"decision_date":251,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET","Sharp Electronics Corp.","1985-09-27",{"k_number":17,"device_name":253,"applicant":254,"decision_date":255,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"BIOCHRON FERTILITY INDICATOR","Fertil-A-Chron, Inc.","1985-09-19",{"k_number":39,"device_name":257,"applicant":258,"decision_date":259,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"RABBIT-PERSONAL COMPUTER FOR WOMEN","Sanimor, Inc.","1985-04-10",{"k_number":22,"device_name":261,"applicant":262,"decision_date":263,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"OVUDATE","Joel R.L. Ehren Kranz","1985-02-15",{"k_number":29,"device_name":265,"applicant":231,"decision_date":266,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"BIOSELF TM 110","1984-12-04",{"k_number":24,"device_name":268,"applicant":269,"decision_date":270,"clearance_type":194,"decision_code":195,"statement_or_summary":80},"RIGHT TIME RHYTHM CLOCK","P.K. Morgan Instruments, Inc.","1983-03-17",{"items":272,"total":79},[]]