Cleared Abbreviated

K141448 - TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K141448 · Teva Medical Ltd., Migada Plant · General Hospital
Jan 2015
Decision
235d
Days
Class 2
Risk

K141448 is an FDA 510(k) clearance for the TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM. Classified as Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), Class II - Special Controls.

Submitted by Teva Medical Ltd., Migada Plant (Rome, IT). The FDA issued a Cleared decision on January 23, 2015 after a review of 235 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K141448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date January 23, 2015
Days to Decision 235 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 169d · This submission: 235d
Pathway characteristics
Standards-based clearance path.

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 15
Devices cleared under the same product code (ONB) and FDA review panel - the closest regulatory comparables to K141448.
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