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 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → LHI — Set, I.V. Fluid Transfer # LHI · Set, I.V. Fluid Transfer _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI ## Overview - **Product Code:** LHI - **Device Name:** Set, I.V. Fluid Transfer - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Classification Rationale Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 205) Showing 20 most recent of 205 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250345](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K250345.md) | Medline Bag Decanter | Medline Industries, LP | Oct 24, 2025 | SESE | | [K251715](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K251715.md) | FlowArt® Vial Access Device Vented | Asset Medikal | Oct 14, 2025 | SESE | | [K251676](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K251676.md) | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | Sep 16, 2025 | SESE | | [K243404](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K243404.md) | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | Jul 18, 2025 | SESE | | [K240761](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240761.md) | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | Mar 21, 2025 | SESE | | [K243985](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K243985.md) | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | Jan 22, 2025 | SESE | | [K243486](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K243486.md) | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | Dec 6, 2024 | SESE | | [K241976](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K241976.md) | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | Sep 6, 2024 | SESE | | [K233287](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K233287.md) | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Jul 26, 2024 | SESE | | [K232987](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K232987.md) | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | Jun 26, 2024 | SESE | | [K240940](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240940.md) | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | May 3, 2024 | SESE | | [K233284](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K233284.md) | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | May 1, 2024 | SESE | | [K240748](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K240748.md) | nextaro® v, 20/20 | Sfm Medical Devices GmbH | Apr 16, 2024 | SESE | | [K233021](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K233021.md) | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | Mar 6, 2024 | SESE | | [K231071](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K231071.md) | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | Jan 19, 2024 | SESE | | [K232875](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K232875.md) | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | Dec 14, 2023 | SESE | | [K230988](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K230988.md) | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | Dec 1, 2023 | SESE | | [K232055](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K232055.md) | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | Oct 6, 2023 | SESE | | [K230464](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K230464.md) | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | May 22, 2023 | SESE | | [K222718](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI/K222718.md) | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Mar 10, 2023 | SESE | ## Top Applicants - Medimop Medical Projects, Ltd. — 11 clearances - Baxter Healthcare Corp — 10 clearances - B.Braun Medical, Inc. — 9 clearances - Baxa Corp., Sub. of Cook Group, Inc. — 7 clearances - Carmel Pharma Ab. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LHI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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