Cleared Special

ProSeal? Transfer Injector (421120, 421130, 421140)

K251722 · Epic Medical Pte. , Ltd. · General Hospital

Dec 2025

Decision

184d

Days

Class 2

Risk

About This 510(k) Submission

K251722 is an FDA 510(k) clearance for the ProSeal? Transfer Injector (421120, 421130, 421140), 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 December 5, 2025, 184 days after receiving the submission on June 4, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251722 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2025
Decision Date	December 05, 2025
Days to Decision	184 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.