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FDA PRODUCT CODE · CLASS II

ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5440
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K251722Epic Medical Pte. , Ltd. · 510k2025-12-05
K253033Simplivia Healthcare , Ltd. · 510k2025-10-21
K250059Becton, Dickinson and Company · 510k2025-09-12
K251411Simplivia Healthcare , Ltd. · 510k2025-08-05
K251340Epic Medical Pte. , Ltd. · 510k2025-05-29
K243976Epic Medical Pte. , Ltd. · 510k2025-01-22
K240517Epic Medical Pte. , Ltd. · 510k2024-12-26
K241988Epic Medical Pte. , Ltd. · 510k2024-10-23

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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