Cleared Special

ProSeal? Bag Spike with Additive Port (423370ST, 423370)

K251340 · Epic Medical Pte. , Ltd. · General Hospital

May 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K251340 is an FDA 510(k) clearance for the ProSeal? Bag Spike with Additive Port (423370ST, 423370), 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 May 29, 2025, 29 days after receiving the submission on April 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251340 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	May 29, 2025
Days to Decision	29 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.