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) → ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System # ONB · Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System _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/ONB ## Overview - **Product Code:** ONB - **Device Name:** Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System - **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) ## 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 41) Showing 20 most recent of 41 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251722](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K251722.md) | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | Dec 5, 2025 | SESE | | [K253033](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K253033.md) | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | Oct 21, 2025 | SESE | | [K250059](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K250059.md) | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) | Becton, Dickinson and Company | Sep 12, 2025 | SESE | | [K251411](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K251411.md) | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | Aug 5, 2025 | SESE | | [K251340](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K251340.md) | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | May 29, 2025 | SESE | | [K243976](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K243976.md) | ZeroClear™ Bag Access (423100) | Epic Medical Pte. , Ltd. | Jan 22, 2025 | SESE | | [K240517](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K240517.md) | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | Dec 26, 2024 | SESE | | [K241988](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K241988.md) | ProSeal™ Closed System Bag Access | Epic Medical Pte. , Ltd. | Oct 23, 2024 | SESE | | [K241735](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K241735.md) | ProSeal™ In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | Oct 10, 2024 | SESE | | [K241823](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K241823.md) | ToxiSeal™ Vial Adaptor | Epic Medical Pte. , Ltd. | Aug 30, 2024 | SESE | | [K241476](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K241476.md) | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | Jun 21, 2024 | SESE | | [K240433](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K240433.md) | ProSeal™ Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | May 21, 2024 | SESE | | [K240171](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K240171.md) | ProSeal™ Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | Mar 28, 2024 | SESE | | [K222929](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K222929.md) | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | Jan 11, 2024 | SESE | | [K231286](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K231286.md) | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | Aug 2, 2023 | SESE | | [K223076](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K223076.md) | BD Texium™ Closed Male Luer | Care Fusion | Mar 24, 2023 | SESE | | [K221513](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K221513.md) | Equashield Closed System Transfer Device | Equashield Medical , Ltd. | Feb 17, 2023 | SESE | | [K201460](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K201460.md) | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | Nov 23, 2022 | SESE | | [K210707](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K210707.md) | OnGuard2 Chemfort Closed Administration (CADM) | Simplivia Healthcare , Ltd. | Sep 23, 2021 | SESE | | [K201422](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB/K201422.md) | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | Mar 2, 2021 | SESE | ## Top Applicants - Epic Medical Pte. , Ltd. — 12 clearances - Simplivia Healthcare , Ltd. — 6 clearances - Becton, Dickinson and Company — 4 clearances - Equashield Medical , Ltd. — 4 clearances - Icu Medical, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/ONB) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com