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CFR §876.5860）の標準的なハイフラックス血液透析器と比較して、中分子量範囲（0.5 kDaから60 kDa）の上限域にある溶質を含む尿毒症性貯留溶質の除去増加を可能にする半透膜への改変を含むものである。","米国ではクラスIIに分類され、市販前届出（510(k)）により安全性・有効性が審査されます。510(k)は、既存の同等な機器（プレディケートデバイス）との実質的同等性を示すことで市販が認められる審査区分であり、クラスIII機器に求められる市販前承認（PMA）よりも簡略化された手続きとなっています。","claude-sonnet-5","323dc878b01734bb4b6b39b77a114ac7218f52e127a368b2796ffcc7f508d80e","2026-08-24T02:35:22.423427+00:00",{"product_code":6,"summary_ja":141,"stats":142,"stats_hash":157,"model_name":137,"created_at":158,"updated_at":158},"本製品コードにおける510(k)の累計件数は2件で、参入企業数は2社、うち直近5年では1件が届出されており、最新の判定は2026年7月となっています。不具合報告（MDR）は累計約5件で、その大半がMalfunction（不具合）であり、傷害報告が1件含まれています。主な問題としてはFluid\u002FBlood Leak（体液・血液の漏れ）、Break（破損）、Contamination of Device Ingredient or Reagent（機器成分・試薬の汚染）が挙げられています。回収（リコール）については累計件数0件であり、クラスI・II・IIIいずれの区分でも確認されていません。",{"pma":143,"k510":144,"as_of":147,"events":148,"recalls":151,"top_problems":153},{"latest":38,"originals":37,"supplements":37},{"total":39,"last5y":145,"latest":146,"applicants":39},1,"2026-07-28","2026-08",{"death":37,"other":37,"total":40,"injury":145,"last5y":40,"malfunction":149,"latest_month":150},4,"2026-01",{"total":37,"last5y":37,"latest":38,"class_i":37,"class_ii":37,"class_iii":37,"top_root_causes":152},[],[154,155,156],"Fluid\u002FBlood Leak","Break","Contamination of Device Ingredient or Reagent","d74f66b1b3ba25d06c0a259173dea5c9420ef4b3c93d7c7dd468829751a14916","2026-08-24T05:15:00.389328+00:00",{"items":160,"total":37},[],{"items":162,"total":39},[163,169],{"k_number":19,"device_name":164,"applicant":165,"decision_date":146,"clearance_type":166,"decision_code":167,"statement_or_summary":168},"ELISIO™-HX","Nipro Medical 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