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., Simplivia Healthcare , Ltd. and Care Fusion.
FDA 510(k) Cleared Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Devices (Product Code ONB)
About Product Code ONB - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code ONB since 2013, with 41 receiving FDA clearance (average review time: 198 days).
Submission volume has increased in recent years - 12 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ONB have taken an average of 111 days to reach a decision - down from 234 days historically, suggesting improved FDA processing for this classification.
ONB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →