Cleared Special

K251340 - ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

K251340 is an FDA 510(k) clearance for ProSeal Bag Spike with Additive Port (4..., manufactured by Epic Medical Pte. , Ltd.. The device is a Class 2 General Hospital device with product code ONB cleared through the Special 510(k) pathway after a 29-day FDA review.

K251340 · Epic Medical Pte. , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
29d
Days
Class 2
Risk

K251340 is an FDA 510(k) clearance for the ProSeal™ Bag Spike with Additive Port (423370ST, 423370). Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 29, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K251340

510(k) Number K251340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

ONB Device Classification - Class 2, Special Controls

Product Code ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

All 40
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K251340.
Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
K253033 · Simplivia Healthcare , Ltd. · Oct 2025
BD PhaSeal™ Optima Connecting Set (C83-O)
K250059 · Becton, Dickinson and Company · Sep 2025
Chemfort Female Luer Lock Adaptor
K251411 · Simplivia Healthcare , Ltd. · Aug 2025
ZeroClear™ Bag Access (423100)
K243976 · Epic Medical Pte. , Ltd. · Jan 2025
ProSeal™ Vented Universal Vial Adaptor
K240517 · Epic Medical Pte. , Ltd. · Dec 2024
ProSeal™ Closed System Bag Access
K241988 · Epic Medical Pte. , Ltd. · Oct 2024
K251340 · ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
Download PDF FDA Summary Epic Medical Pte. , L…