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Pump, Infusion, Elastomeric（MEB）
エラストマー式輸液ポンプ この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
109 件
直近 2019.09.04
88 件
0 件
33,515 件
分類情報
| Product Code | MEB |
|---|---|
| デバイス名 | Pump, Infusion, Elastomeric エラストマー式輸液ポンプ この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 880.5725 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 一般病院用 |
| 定義 | － |
| フラグ | 該当なし |
| AI分析 | 本機器は、伸縮性のあるエラストマー素材でできたリザーバーの収縮力を利用して、薬液や輸液を一定の速度で持続的に注入するポンプです。電源を必要とせず、携行性に優れていることから、在宅医療や外来での持続注入療法に用いられます。米国ではクラスIIに分類され、市販前届出（510(k)）により既存同等機器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となっています。 米国市場での動向 510(k)は累計約90件で、参入企業は42社、直近5年間の件数は約3件です。不具合報告（MDR）は累計約33,400件で、その大半がMalfunction（不具合）に分類され、死亡は57件、傷害は約2,000件となっており、主な問題としてFilling Problem、Fluid/Blood Leak、No Flowが挙げられています。回収は累計約110件で、うちクラスI（最重篤）が14件、クラスIIが28件、クラスIIIは確認されていません。最新の回収開始時期は2019年5月で、直近5年間の新規回収は確認されていません。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
関連 product code
同じ 21 CFR 880.5725 に分類される product code（16 件）
| No. | product code | 機器名 | クラス | 専門分野 | 510(k) | PMA | 不具合 | 回収 |
|---|---|---|---|---|---|---|---|---|
| 1 | FRN | Pump, Infusion 輸液ポンプ | II | 一般病院用 | 849 | — | 1,831,043 | 718 件 |
| 2 | LZG | Pump, Infusion, Insulin インスリン輸液ポンプ | II | 一般病院用 | 85 | — | 539,953 | 126 件 |
| 3 | LGZ | Warmer, Thermal, Infusion Fluid 輸液加温装置 | II | 一般病院用 | 75 | — | 7,002 | 32 件 |
| 4 | LDR | Controller, Infusion, Intravascular, Electronic 電子式血管内輸液コントローラ | II | 一般病院用 | 60 | — | 73 | 5 件 |
| 5 | MRZ | Accessories, Pump, Infusion 輸液ポンプ用アクセサリ | II | 一般病院用 | 48 | — | 540 | 8 件 |
| 6 | LZH | Pump, Infusion, Enteral 経腸栄養用輸液ポンプ | II | 一般病院用 | 34 | — | 14,922 | 24 件 |
| 7 | MEA | Pump, Infusion, Pca PCA用輸液ポンプ | II | 一般病院用 | 31 | — | 32,858 | 46 件 |
| 8 | MRH | Pump, Infusion, Ophthalmic 眼科用輸液ポンプ | II | 一般病院用 | 20 | — | 138 | — |
| 9 | PHC | Infusion Safety Management Software 輸液安全管理ソフトウェア | II | 一般病院用 | 10 | — | 88 | 13 件 |
| 10 | LZF | Pump, Infusion, Analytical Sampling 分析サンプリング輸液ポンプ | II | 一般病院用 | 7 | — | 2 | 1 件 |
| 11 | OPP | Pump, Infusion, Insulin Bolus インスリンボーラス注入ポンプ | II | 一般病院用 | 7 | — | 36 | 1 件 |
| 12 | PKP | Immunoglobulin G (Igg) Infusion System 免疫グロブリンG注入システム | II | 一般病院用 | 7 | — | 7 | — |
機器名の日本語訳は AI により自動生成したものです。正確には英語原文をご確認ください。
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 内臓機能検査用器具 | インフュージョンポンプクラスⅡ | 1 | 1 | — | — | — | — |
| 2 | 医薬品注入器 | 経腸栄養用輸液ポンプクラスⅢ | 14 | 7 | 0.67 億円/年 | -31.8% | 5.14 万円/個 | 43.9% |
| 3 | 医薬品注入器 | 汎用輸液ポンプクラスⅢ | 49 | 13 | 30.36 億円/年 | -24.9% | 9.28 万円/個 | 92.0% |
| 4 | 医薬品注入器 | 注射筒輸液ポンプクラスⅢ | 30 | 11 | 29.72 億円/年 | -13.3% | 17.82 万円/個 | 98.8% |
| 5 | 医薬品注入器 | 非静注インフュージョンポンプクラスⅡ | 3 | 2 | — | — | — | — |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 109 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-2360-2019 MEB | クラス II | 2019.05.23 | Leventon S. A. U. | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. | 終了 |
| Z-0956-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0955-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0954-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0953-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0952-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0951-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0950-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0949-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0948-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0947-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0946-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0945-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0944-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0943-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0942-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0941-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-0940-2019 MEB | クラス II | 2018.10.02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration. | 終了 |
| Z-2655-2014 MEB | クラス II | 2014.08.06 | B. Braun Medical, Inc. | The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100. | 終了 |
| Z-0921-2014 MEB | クラス II | 2013.12.13 | B. Braun Medical, Inc. | Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications. | 終了 |
510(k)（市販前届出）
全 88 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026.04.24 | 通常（Traditional） | |
| 2 | K240624 | InfuLife | First Medical Source, LLC | 2024.11.05 | 通常（Traditional） | |
| 3 | K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | 2024.10.07 | 特別（Special） | |
| 4 | K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019.03.22 | 通常（Traditional） | |
| 5 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016.04.04 | 通常（Traditional） | |
| 6 | K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | 2014.02.03 | 通常（Traditional） | |
| 7 | K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | 2013.08.14 | 通常（Traditional） | |
| 8 | K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | 2009.04.30 | 特別（Special） | |
| 9 | K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008.07.15 | 通常（Traditional） | |
| 10 | K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008.02.19 | 通常（Traditional） | |
| 11 | K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | 2007.11.26 | 特別（Special） | － |
| 12 | K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | 2007.11.06 | 通常（Traditional） | |
| 13 | K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2007.07.19 | 特別（Special） | |
| 14 | K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | 2007.05.25 | 特別（Special） | |
| 15 | K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | I-Flow Corp. | 2007.01.26 | 特別（Special） | |
| 16 | K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | Advanced Infusion, Inc. | 2006.10.18 | 通常（Traditional） | |
| 17 | K062457 | INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corporation | 2006.09.21 | 特別（Special） | |
| 18 | K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET | Precise Medical Products, Ltd. | 2006.06.16 | 特別（Special） | |
| 19 | K060258 | AUTOFUSER | Ace Medical Us, LLC | 2006.05.30 | 通常（Traditional） | |
| 20 | K060933 | SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM | Apex Medical Technologies, Inc. | 2006.05.09 | 通常（Traditional） |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。