Cleared Traditional

K222929 - ToxiSeal Vial Adapter with External Balloon (FDA 510(k) Clearance)

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

K222929 · Epic Medical Pte. , Ltd. · General Hospital
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Jan 2024
Decision
472d
Days
Class 2
Risk

K222929 is an FDA 510(k) clearance for the ToxiSeal Vial Adapter with External Balloon. 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 January 11, 2024 after a review of 472 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Epic Medical Pte. , Ltd. devices

Submission Details

510(k) Number K222929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date January 11, 2024
Days to Decision 472 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
344d slower than avg
Panel avg: 128d · This submission: 472d
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 K222929.
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