[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-BYP":3},{"classification":4,"mappedDevices":241,"similarCandidates":242,"relatedClassifications":314,"syncDates":315,"translation":322,"marketSummary":328,"recalls":348,"k510s":350,"pmas":425},{"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":235,"updated_at":236,"recall_count":237,"latest_recall_date":238,"k510_count":239,"pma_count":237,"event_count":240},921,"BYP","Mouthpiece, Breathing","1","868.5620","AN","Anesthesiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":233,"product_code":6,"review_panel":10,"gmp_exempt_flag":233,"third_party_flag":233,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":233,"medical_specialty_description":11,"summary_malfunction_reporting":234},{"k_number":17,"fei_number":43,"registration_number":208},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"K761297","K840459","K790066","K865093","K853575","K790933","K853572","K853402","K810793","K853266","K770586","K790932","K803069","K853574","K833420","K791537","K893791","K872037","K955657","K944512","K863049","K862788","K822437","K790931","K821128",[44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207],"3027320022","3008294339","1000604079","3013600135","3006547005","3015378469","3010882708","3007740533","3001237338","3016450032","3015781296","3002558692","3012314549","3014739961","3010957755","3015495690","3010287621","1000520092","3000126629","3004612204","3033959233","3012896103","3002807267","3003674698","1000154583","3012309743","3045058049","3015745029","3016218294","3042261316","1924066","3007187674","3014810929","3008317830","3020614","3011647251","3004476631","3014236293","3015142701","3012365569","3031369651","3002750084","3002807293","3008386507","3010817335","3014916466","3018783526","3023917","2025816","3009095356","3013463240","1030186","3003256355","3015422337","3031288561","3006061749","2427500","3002808458","3003496134","3026818268","3008485841","3029917416","3010515776","3004216008","3005273623","3006621348","3013548509","3013557562","3011987967","3017248108","3006517436","1000524541","3018762668","3002806708","3038562397","2433214","3017202422","3011587055","3010131137","3011185837","3023809973","2518157","2023529","3020777588","3030446844","3003862188","3013632692","3012002722","3003383868","3017676696","3004365956","3008427684","3012970776","3012034017","3022568093","1417592","3023895623","3003887292","2518422","3023272766","3014268398","3017417635","3023464160","3006657376","3008808082","3012250536","3014866140","1000271197","3006363476","3006534321","3005460813","3008505660","3003418980","2518436","1000484830","3004050971","1220018","3006157842","3002808182","3006419626","3010583519","1000121059","3009488612","3011905669","3013856565","1024404","1314417","3015168843","3001106688","3010402691","3012494290","3014314529","3006783791","3011835632","3012329712","3009171220","3002673652","3008205331","3015168527","3030455652","3029706818","3013000203","3012026312","3024821684","1220253","3014059993","3008806809","3016750005","1000283452","2050098","1000374126","3013226","3002963732","3030795695","3022106572","3016678045","3011280379","3007128724","3007649127","3004213967","3013766601","3005747797","1000159424","3017299525",[44,45,46,47,48,49,50,51,53,54,209,56,57,58,210,211,59,60,212,64,65,66,67,68,69,213,70,71,214,72,73,74,75,76,77,78,79,80,81,82,215,83,84,87,88,89,90,216,91,92,217,93,94,97,98,99,100,101,102,103,104,105,106,218,219,220,108,109,110,111,112,113,114,116,118,119,120,121,122,123,124,125,126,127,128,221,129,130,131,132,133,134,135,136,222,137,138,139,140,141,142,143,144,223,145,224,146,147,148,225,149,150,153,154,155,157,226,158,159,227,160,161,228,163,164,229,166,167,168,169,170,171,172,173,174,175,176,177,178,179,182,183,230,184,185,186,187,231,188,189,190,191,193,195,197,198,199,232,200,201,202,204,62,207],"9610639","1025972","3001313714","9616354","1222276","8030978","1225492","2133542","9616567","9680411","8040278","9614485","9615102","1836161","3029845","3011137372","9617604","8030673","9710567","8021995","2028807","8044169","9614860","1223651","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.493322+00:00",0,null,25,11,[],[243,251,259,266,273,280,287,294,301,307],{"medical_device_id":244,"generic_name":245,"class_classification":246,"jmdn_code":247,"name_similarity":248,"definition_similarity":237,"vector_similarity":249,"score":250},4286,"内視鏡用マウスピース","Ⅰ","70951000",0.34375,0.723494,0.0325225,{"medical_device_id":252,"generic_name":253,"class_classification":254,"jmdn_code":255,"name_similarity":256,"definition_similarity":237,"vector_similarity":257,"score":258},1982,"単回使用マウスピースコネクタ","Ⅱ","44545000",0.292683,0.695232,0.0312805,{"medical_device_id":260,"generic_name":261,"class_classification":254,"jmdn_code":262,"name_similarity":263,"definition_similarity":237,"vector_similarity":264,"score":265},1981,"再使用可能なマウスピースコネクタ","43467000",0.275,0.669942,0.0303309,{"medical_device_id":267,"generic_name":268,"class_classification":246,"jmdn_code":269,"name_similarity":270,"definition_similarity":237,"vector_similarity":271,"score":272},3925,"呼吸ガスミキサ","70563000",0.323529,0.627925,0.0279707,{"medical_device_id":274,"generic_name":275,"class_classification":254,"jmdn_code":276,"name_similarity":277,"definition_similarity":237,"vector_similarity":278,"score":279},2425,"単回使用麻酔用呼吸回路","37704000",0.196078,0.6594,0.0277303,{"medical_device_id":281,"generic_name":282,"class_classification":254,"jmdn_code":283,"name_similarity":284,"definition_similarity":237,"vector_similarity":285,"score":286},2409,"単回使用人工呼吸器呼吸回路","37706000",0.2,0.65231,0.0274254,{"medical_device_id":288,"generic_name":289,"class_classification":254,"jmdn_code":290,"name_similarity":291,"definition_similarity":237,"vector_similarity":292,"score":293},2415,"空気・酸素非再呼吸式マスク","35173000",0.204545,0.640677,0.0266856,{"medical_device_id":295,"generic_name":296,"class_classification":254,"jmdn_code":297,"name_similarity":298,"definition_similarity":237,"vector_similarity":299,"score":300},2416,"部分再呼吸式マスク","35174000",0.243243,0.626171,0.0263339,{"medical_device_id":302,"generic_name":303,"class_classification":254,"jmdn_code":304,"name_similarity":284,"definition_similarity":237,"vector_similarity":305,"score":306},2434,"再使用可能な麻酔用呼吸回路","37021000",0.63631,0.0261717,{"medical_device_id":308,"generic_name":309,"class_classification":246,"jmdn_code":310,"name_similarity":311,"definition_similarity":237,"vector_similarity":312,"score":313},4285,"鼻息鏡","70950000",0.205882,0.629463,0.0261449,[],{"510k":316,"classification":317,"enforcement":318,"event":319,"pma":320,"warning_letter":321},"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":323,"definition_ja":238,"commentary_ja":324,"model_name":325,"source_hash":326,"reviewed_by":238,"reviewed_at":238,"created_at":327,"updated_at":327},"呼吸用マウスピース","本品は米国FDAの分類においてクラスIに区分される医療機器であり、麻酔科領域で使用される呼吸用マウスピースです。クラスIはリスクが最も低い機器区分であり、本品は510(k)の届出も免除されているため、市販前届出および市販前承認のいずれの手続きも不要とされています。","claude-sonnet-5","c94db5083daed38673411aaa7aa60073da0ad25fac8408ba304484649fb7c6bd","2026-08-24T01:44:46.715951+00:00",{"product_code":6,"summary_ja":329,"stats":330,"stats_hash":346,"model_name":325,"created_at":347,"updated_at":347},"510(k)届出は累計約25件で、参入企業は16社に上りますが、直近5年間の届出およびPMAの承認実績は確認されていません。不具合報告は累計約10件で、死亡1件、傷害4件、不具合4件、その他2件が報告されており、直近5年では約2件、最新の報告は2025年6月です。主な問題として、患者と機器の不適合（Patient-Device Incompatibility）や部材の割れ・切れ・破れ（Material Split, Cut or Torn）が挙げられています。回収については累計・直近5年ともに確認されていません。",{"pma":331,"k510":332,"as_of":335,"events":336,"recalls":341,"top_problems":343},{"latest":238,"originals":237,"supplements":237},{"total":239,"last5y":237,"latest":333,"applicants":334},"1996-03-12",16,"2026-08",{"death":337,"other":338,"total":240,"injury":339,"last5y":338,"malfunction":339,"latest_month":340},1,2,4,"2025-06",{"total":237,"last5y":237,"latest":238,"class_i":237,"class_ii":237,"class_iii":237,"top_root_causes":342},[],[344,345],"Patient-Device Incompatibility","Material Split, Cut or Torn","9e82018d5fba091a1170ec0326afdec7f8783007ff6d7869babc1af52b5940a3","2026-08-24T04:10:52.385113+00:00",{"items":349,"total":237},[],{"items":351,"total":239},[352,358,362,366,369,373,377,381,384,386,388,391,395,399,402,405,409,413,417,421],{"k_number":36,"device_name":353,"applicant":354,"decision_date":333,"clearance_type":355,"decision_code":356,"statement_or_summary":357},"NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE","North State Plastics, Inc.","Traditional","SESE","Summary",{"k_number":37,"device_name":359,"applicant":360,"decision_date":361,"clearance_type":355,"decision_code":356,"statement_or_summary":357},"TRUZONE PFM DISPOSABLE MOUTHPIECE","Monaghan Medical Corp.","1994-11-02",{"k_number":34,"device_name":363,"applicant":364,"decision_date":365,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"BREATHING MOUTHPIECE","Diemolding Corp.","1989-06-23",{"k_number":35,"device_name":367,"applicant":360,"decision_date":368,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"AEROCHAMBER","1987-07-24",{"k_number":21,"device_name":370,"applicant":371,"decision_date":372,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"SAFE-T-SHIELD MOUTHPIECE","Medi Nuclear Corp., Inc.","1987-01-15",{"k_number":38,"device_name":374,"applicant":375,"decision_date":376,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"INHALATION AID","Boehringer Ingelheim Pharmaceuticals, Inc.","1986-10-15",{"k_number":39,"device_name":378,"applicant":379,"decision_date":380,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MP-4400 MOUTHPIECE-FLANGE SEAL","Medipart Jerry Alexander","1986-08-01",{"k_number":22,"device_name":382,"applicant":379,"decision_date":383,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MEDIPART MOUTHPIECE MP-1010","1985-10-29",{"k_number":31,"device_name":385,"applicant":379,"decision_date":383,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MEDIPART DISPOS. MOUTHPIECE W\u002F22MM O.D. MP-4411",{"k_number":24,"device_name":387,"applicant":379,"decision_date":383,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MEDIPART DISPOS. MOUTHPIECE W\u002F2MM I.D. MP-4410",{"k_number":27,"device_name":389,"applicant":390,"decision_date":383,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"PLASTIC MOUTH BARRIER HSV-I","Westmark Enterprises, Inc.",{"k_number":25,"device_name":392,"applicant":393,"decision_date":394,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"E-Z-GUARD MOUTHPIECE","E-Z-Em, Inc.","1985-10-23",{"k_number":19,"device_name":396,"applicant":397,"decision_date":398,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"IMPROVED MOUTHPIECE","Kinetix","1984-02-17",{"k_number":32,"device_name":400,"applicant":397,"decision_date":401,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"KINETIX MOUTHPIECE","1984-01-10",{"k_number":40,"device_name":403,"applicant":360,"decision_date":404,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MONAGHAN AEROCHAMBER","1982-11-03",{"k_number":42,"device_name":406,"applicant":407,"decision_date":408,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"DISPOSABLE THERMOPLASTIC RUBBER MOUTH","Airlife, Inc.","1982-05-13",{"k_number":26,"device_name":410,"applicant":411,"decision_date":412,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MOUTHPIECE, BREATHING","Dhd Medical Products Div. Diemolding Corp.","1981-05-05",{"k_number":30,"device_name":414,"applicant":415,"decision_date":416,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"SHELL KRATON THERMO-PLASTIC RUBBER COMP.","Warren E. Collins, Inc.","1980-12-22",{"k_number":33,"device_name":418,"applicant":419,"decision_date":420,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"DISPOSABLE MOUTHPIECE","Hospitak, Inc.","1979-09-07",{"k_number":23,"device_name":422,"applicant":423,"decision_date":424,"clearance_type":355,"decision_code":356,"statement_or_summary":238},"MOUTHPIECE M-187","Mem Medical, Inc.","1979-05-21",{"items":426,"total":237},[]]