FDA Product Code ONB: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Handling hazardous chemotherapy drugs poses significant risks to healthcare workers. FDA product code ONB covers closed-system drug reconstitution and transfer devices for antineoplastic and hazardous drugs.
These systems mechanically prevent the escape of hazardous vapors and aerosols during the preparation and transfer of chemotherapy agents, protecting pharmacy staff and nurses from toxic exposure while maintaining drug sterility.
ONB devices are Class II medical devices, regulated under 21 CFR 880.5440 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Epic Medical Pte. , Ltd., Care Fusion and Becton, Dickinson and Company.
List of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System devices (product code ONB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →