Cleared Special

K170680 - TEVADAPTOR Closed Drug Reconstitution a...

K170680 is the FDA 510(k) clearance for TEVADAPTOR Closed Drug Reconstitution a... by Teva Medical Ltd., Migada Plant. It is a Class 2 General Hospital device (product code ONB) cleared through the Special 510(k) pathway after a 71-day FDA review.

K170680 · Teva Medical Ltd., Migada Plant · General Hospital
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May 2017
Decision
71d
Days
Class 2
Risk

K170680 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 (Kiryat Shmona, IL). The FDA issued a Cleared decision on May 16, 2017 after a review of 71 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.

View all Teva Medical Ltd., Migada Plant devices

Submission Details

510(k) Number K170680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date May 16, 2017
Days to Decision 71 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 35
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