Cleared Traditional

K240517 - ProSeal™ Vented Universal Vial Adaptor (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240517 · Epic Medical Pte. , Ltd. · General Hospital
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Dec 2024
Decision
307d
Days
Class 2
Risk

K240517 is an FDA 510(k) clearance for the ProSeal™ Vented Universal Vial Adaptor. 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 December 26, 2024 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epic Medical Pte. , Ltd. devices

Submission Details

510(k) Number K240517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date December 26, 2024
Days to Decision 307 days
Submission Type Traditional
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
179d slower than avg
Panel avg: 128d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K240517.
ProSeal™ Transfer Injector (421120, 421130, 421140)
K251722 · Epic Medical Pte. , Ltd. · Dec 2025
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
ProSeal™ Bag Spike with Additive Port (423370ST, 423370)
K251340 · Epic Medical Pte. , Ltd. · May 2025
ZeroClear™ Bag Access (423100)
K243976 · Epic Medical Pte. , Ltd. · Jan 2025