Cleared Traditional

BD Texium? Closed Male Luer

K223076 · Care Fusion · General Hospital

Mar 2023

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K223076 is an FDA 510(k) clearance for the BD Texium? Closed Male Luer, a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on March 24, 2023, 175 days after receiving the submission on September 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K223076 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	March 24, 2023
Days to Decision	175 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
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.