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Discretion）の対象として扱われています。これは、既に個別に承認・許可されている複数の製品を利便性のために一つのキットとしてまとめた「コンビニエンスキット」に特有の規制上の位置づけであり、ガイダンスに示された基準を満たすことが条件となります。","claude-sonnet-5","49fc06942fe36285d2c26869db61a408c143d26fc89a652cb23cf35681876a93","2026-08-24T01:48:55.976021+00:00",{"product_code":6,"summary_ja":147,"stats":148,"stats_hash":161,"model_name":143,"created_at":162,"updated_at":162},"510(k)の累計件数は7件で、参入企業数は6社ですが、直近5年の届出や最新の判定は1985年7月以降確認されていません。不具合報告は累計約6件で、死亡報告はなく、傷害が2件、不具合（Malfunction）が3件となっており、主な問題としてMaterial Integrity Problem（材料の完全性に関する問題）が挙げられています。回収については累計件数が確認されていません。",{"pma":149,"k510":150,"as_of":152,"events":153,"recalls":157,"top_problems":159},{"latest":46,"originals":45,"supplements":45},{"total":47,"last5y":45,"latest":151,"applicants":48},"1985-07-02","2026-08",{"death":45,"other":56,"total":48,"injury":154,"last5y":56,"malfunction":155,"latest_month":156},2,3,"2026-07",{"total":45,"last5y":45,"latest":46,"class_i":45,"class_ii":45,"class_iii":45,"top_root_causes":158},[],[160],"Material 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