Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5025](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5025) → KPE — Container, I.V. # KPE · Container, I.V. _General Hospital · 21 CFR 880.5025 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE ## Overview - **Product Code:** KPE - **Device Name:** Container, I.V. - **Regulation:** [21 CFR 880.5025](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5025) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 117) Showing 20 most recent of 117 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252079](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K252079.md) | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | Apr 2, 2026 | SESE | | [K251980](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K251980.md) | ClaveQS™ Bag | Icu Medical, Inc. | Mar 20, 2026 | SESE | | [K251139](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K251139.md) | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | Jan 9, 2026 | SESE | | [K252094](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K252094.md) | eZSURE™ Empty Fluid Container | Epic Medical Pte. , Ltd. | Aug 1, 2025 | SESE | | [K250459](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K250459.md) | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. | Apr 18, 2025 | SESE | | [K241442](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K241442.md) | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte. , Ltd. | Jun 21, 2024 | SESE | | [K223674](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K223674.md) | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. | Sep 1, 2023 | SESE | | [K222622](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K222622.md) | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | Feb 16, 2023 | SESE | | [K210749](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K210749.md) | Empty EVA Bag | Haemotronic S.P.A. | Aug 19, 2021 | SESE | | [K201936](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K201936.md) | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | May 6, 2021 | SESE | | [K193528](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K193528.md) | Empty EVA Bag | Haemotronic S.P.A. | Jul 22, 2020 | SESE | | [K190328](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K190328.md) | HCT Empty EVA Container Pack | Health Care Technologies | Aug 15, 2019 | SESE | | [K190305](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K190305.md) | Additive Cap | International Medical Industries, Inc. | Apr 30, 2019 | SESE | | [K181393](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K181393.md) | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP | Valmed S.R.L. | Feb 15, 2019 | SESE | | [K132276](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K132276.md) | STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML | Hospira, Inc. | Nov 12, 2013 | SESE | | [K121161](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K121161.md) | EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER | Acta Medical, LLC | Jul 13, 2012 | SESE | | [K111217](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K111217.md) | ADDITIVE CAP | Baxter Healthcare Corp | Jun 14, 2011 | SESE | | [K101412](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K101412.md) | EVA TPN BAG | Valmed S.R.L. | Apr 13, 2011 | SESE | | [K090096](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K090096.md) | ALL-IN-ONE CONTAINER | Baxter Healthcare Corporation | Jan 30, 2009 | SESE | | [K073538](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE/K073538.md) | DUAL CHAMBER TPN CONTAINER | B.Braun Medical, Inc. | Mar 12, 2008 | SESE | ## Top Applicants - Baxter Healthcare Corp — 7 clearances - Abbott Laboratories — 6 clearances - Baxa Corp., Sub. of Cook Group, Inc. — 5 clearances - Gil-Med Industries C/O Kegan & Kegan, Ltd. — 4 clearances - Medi-Plast Intl., Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KPE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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