# K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System

- Pathway: 510(k) (Traditional)
- Applicant: Teva Medical Ltd., Migada Plant
- Decided: Sep 21, 2018 after 210 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K883614 (1988). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System, Teva Medical Ltd., Migada Plant (2015) Summary page 6.

## Most influential descendants
- K231286: Chemfort® Catheter Adaptor (2023), 0 descendants of its own

## Indications for use
TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.

Source page: https://510kreport.com/device/K180489
Methodology: https://510kreport.com/methodology