Cleared Special

ZeroClear? Bag Access (423100)

K243976 · Epic Medical Pte. , Ltd. · General Hospital

Jan 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K243976 is an FDA 510(k) clearance for the ZeroClear? Bag Access (423100), a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II — Special Controls, product code ONB), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on January 22, 2025, 30 days after receiving the submission on December 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K243976 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	January 22, 2025
Days to Decision	30 days
Submission Type	Special
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.