ONB

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Product code

ONB

Device name

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Device class

Class 2

21 CFR

21 CFR 880.5440

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

14

Summaries archived here

13 (direct download)

510(k) clearances (all years, FDA)

41 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (14)

Last three years. Most recent: 2025-12-05.

13 summaries are archived here for direct download.