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) → FPA — Set, Administration, Intravascular # FPA · Set, Administration, Intravascular _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/FPA ## Overview - **Product Code:** FPA - **Device Name:** Set, Administration, Intravascular - **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 1174) Showing 20 most recent of 1174 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251375](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K251375.md) | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | Feb 12, 2026 | SESE | | [K251257](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K251257.md) | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | Dec 4, 2025 | SESE | | [K250325](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K250325.md) | BD Alaris Pump Infusion Set | Carefusion (Bd) | Oct 30, 2025 | SESE | | [K251814](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K251814.md) | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | Aug 29, 2025 | SESE | | [K251854](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K251854.md) | SteadiSet infusion set | Tandem Diabetes Care | Aug 6, 2025 | SESE | | [K243841](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K243841.md) | Sparta Infusion Set for Insulin | Deka Research and Development | Aug 1, 2025 | SESE | | [K243392](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K243392.md) | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | Jul 24, 2025 | SESE | | [K250616](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K250616.md) | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | Jun 5, 2025 | SESE | | [K242692](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K242692.md) | SteadiSet Infusion Set | Capillary Biomedical, LLC | May 9, 2025 | SESE | | [K242763](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K242763.md) | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | May 2, 2025 | SESE | | [K243529](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K243529.md) | Solution Administration Sets | Baxter Healthcare Corporation | Mar 14, 2025 | SESE | | [K242339](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K242339.md) | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | Feb 28, 2025 | SESE | | [K241058](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K241058.md) | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | Dec 18, 2024 | SESE | | [K234129](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K234129.md) | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | Sep 20, 2024 | SESE | | [K242126](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K242126.md) | I.V. Administration Set | Bq Plus Medical Co., Ltd. | Aug 22, 2024 | SESE | | [K232475](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K232475.md) | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | May 10, 2024 | SESE | | [K222766](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K222766.md) | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | Apr 12, 2024 | SESE | | [K232328](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K232328.md) | Insignis™ Syringe Infusion System | Innovative Health Sciences, LLC | Mar 1, 2024 | SESE | | [K231707](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K231707.md) | ResQ Administration Set | Q For Plastic Industries | Jan 3, 2024 | SESE | | [K230528](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K230528.md) | Extension Set | Medcaptain Life Science Co., Ltd. | Dec 1, 2023 | SESE | ## Top Applicants - Baxter Healthcare Corp — 51 clearances - Abbott Laboratories — 30 clearances - Y — 28 clearances - Icu Medical, Inc. — 27 clearances - Sterling Medivations, Inc. — 24 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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