510(k) K251340

ProSeal Bag Spike with Additive Port (423370ST, 423370) by Epic Medical Pte. , Ltd. — Product Code ONB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 29, 2025
Date Received: April 30, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class: Class II
Regulation Number: 880.5440
Review Panel: HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Other clearances by Epic Medical Pte. , Ltd.

K251722 — ProSeal Transfer Injector (421120, 421130, 421140) (December 5, 2025)
K251814 — EZ IV Administration Set (August 29, 2025)
K252094 — eZSURE Empty Fluid Container (August 1, 2025)
K243976 — ZeroClear Bag Access (423100) (January 22, 2025)
K240517 — ProSeal Vented Universal Vial Adaptor (December 26, 2024)
K241988 — ProSeal Closed System Bag Access (October 23, 2024)
K241735 — ProSeal In Line Pump Set (423850) (October 10, 2024)
K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
K241823 — ToxiSeal Vial Adaptor (August 30, 2024)
K241476 — ToxiSeal Vial Adaptor with External Flip Balloon (June 21, 2024)

Other clearances for product code ONB

K251722 — ProSeal Transfer Injector (421120, 421130, 421140) (December 5, 2025)
K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (October 21, 2025)
K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) (September 12, 2025)
K251411 — Chemfort Female Luer Lock Adaptor (August 5, 2025)
K243976 — ZeroClear Bag Access (423100) (January 22, 2025)
K240517 — ProSeal Vented Universal Vial Adaptor (December 26, 2024)
K241988 — ProSeal Closed System Bag Access (October 23, 2024)
K241735 — ProSeal In Line Pump Set (423850) (October 10, 2024)
K241823 — ToxiSeal Vial Adaptor (August 30, 2024)
K241476 — ToxiSeal Vial Adaptor with External Flip Balloon (June 21, 2024)