K180489 - TEVADAPTOR Closed Drug Reconstitution and Transfer System (FDA 510(k) Clearance)

K180489 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 September 21, 2018 after a review of 210 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.