K170680 - TEVADAPTOR Closed Drug Reconstitution and Transfer System (FDA 510(k) Clearance)

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.