510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONBClass II

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

ONB is the FDA product code for Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, a class II device type, regulated under 21 CFR 880.5440. FDA's definition for this code reads: "Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting". As of , FDA records hold 41 510(k) clearances under this code, the most recent dated , and 71 recalls.

Classification record

Product code
ONB
Device name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
FDA 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.
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
41
Ingested recalls
73

Clearances, product code ONB

By decision year
41 clearances under product code ONB with a decision year between 2013 and 2025, 2024 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code ONB by decision year
YearClearances
20133
20142
20153
20172
20186
20191
20203
20213
20221
20233
20248
20256

Applicants with the most clearances

Product code ONB
Applicants holding the most 510(k) clearances under product code ONB
ApplicantClearances
Epic Medical Pte., Ltd.12
Becton Dickinson & Co6
Simplivia Healthcare Ltd.6
Equashield Medical Ltd4
Abbott Medical4
Teva Medical Ltd., Migada Plant3
J & J Solutions, Inc. D/B/A/ Corvida Medical2
Care Fusion1
JMS North America Corp.1
Shinva Ande Healthcare Apparatus Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order