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CFR 868.5590に基づきクラスIに分類されており、市販前届出（510(k)）が免除される品目として扱われています。これはリスクが比較的低く、既存の安全性・有効性の実績が確立されている機器に適用される区分です。","claude-sonnet-5","14450756fe43a89ad65071f298b4bb6450fc85e8ab95a136db00c622113cc067","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":327,"stats":328,"stats_hash":344,"model_name":323,"created_at":345,"updated_at":345},"本製品は届出免除の対象であり、510(k)の累計件数は1件、参入企業数は1社で、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8件で、不具合（Malfunction）が中心を占め、死亡・傷害の報告は確認されていません。主な問題としては、Patient Device Interaction Problem（患者と機器の相互作用に関する問題）、Device Markings\u002FLabelling Problem（機器の表示・ラベリングに関する問題）、Inadequate Instructions for Non-Healthcare Professional（非医療従事者向け説明の不備）が挙げられています。回収については、累計件数・クラスI〜IIIのいずれも0件で、記録は確認されていません。",{"pma":329,"k510":330,"as_of":332,"events":333,"recalls":338,"top_problems":340},{"latest":235,"originals":234,"supplements":234},{"total":236,"last5y":234,"latest":331,"applicants":236},"1997-03-28","2026-08",{"death":234,"other":334,"total":237,"injury":234,"last5y":335,"malfunction":336,"latest_month":337},2,4,6,"2022-11",{"total":234,"last5y":234,"latest":235,"class_i":234,"class_ii":234,"class_iii":234,"top_root_causes":339},[],[341,342,343],"Patient Device Interaction Problem","Device Markings\u002FLabelling Problem","Inadequate Instructions for Non-Healthcare Professional","cd598a45ad19bd4b67429337f0399922eed1dabe6bfc0051a87233e918b799b8","2026-08-24T04:44:46.948226+00:00",{"items":347,"total":234},[],{"items":349,"total":236},[350],{"k_number":18,"device_name":351,"applicant":352,"decision_date":331,"clearance_type":353,"decision_code":354,"statement_or_summary":355},"UNIVERSAL LOW PROFILE NASAL 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