Cleared Abbreviated

K141448 - TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K141448 is an FDA 510(k) clearance for TEVADAPTOR CLOSED DRUG RECONSTITUTION A..., manufactured by Teva Medical Ltd., Migada Plant. The device is a Class 2 General Hospital device with product code ONB cleared through the Abbreviated 510(k) pathway after a 235-day FDA review.

K141448 · Teva Medical Ltd., Migada Plant · General Hospital
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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.

View all Teva Medical Ltd., Migada Plant devices

FDA 510(k) Submission Details - K141448

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 129d · This submission: 235d
Pathway characteristics
Standards-based clearance path.

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 K141448.
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K170680 · Teva Medical Ltd., Migada Plant · May 2017
Equashield Closed System drug Transfer Device (CSTD)
K150219 · Equashield Medical , Ltd. · Nov 2015
Halo
K150486 · J & J Solutions, Inc. D/B/A/ Corvida Medical · Jul 2015
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
K140591 · Becton, Dickinson & CO · May 2014
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
K132899 · Equashield Medical , Ltd. · May 2014
CHEMOLOCK, CHEMOLOCK PORT
K131549 · Icu Medical, Inc. · Jul 2013