# K141448: Tevadaptor Closed Drug Reconstitution and Transfer System

- Pathway: 510(k) (Abbreviated)
- Applicant: Teva Medical Ltd., Migada Plant
- Decided: Jan 23, 2015 after 235 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: 8 generations back to K883614 (1988). 34 ancestors in all.
9 later devices descend from it; 4 cite it directly.
3 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071741: Tevadaptor, Closed Drug Reconstitution and Transfer System, Migada Plant (2007) Summary page 5.
- K123213: BD Phaseal Closed System Transfer Device, Becton, Dickinson & CO (2013) Summary page 7.
- K130197: BD Phaseal Closed System Transfer Device - P55, Becton, Dickinson and Company (2013) Summary page 7.
- K131549: Chemolock, Chemolock Port, Icu Medical, Inc. (2013) Summary page 7.

## Most influential descendants
- K192866: Chemfort CSTD (2020), 3 descendants of its own
- K201422: Arisure Closed System Drug Transfer Device (CSTD) (2021), 1 descendant of its own
- K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System (2018), 1 descendant of its own
- K253033: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (2025), 0 descendants of its own
- K251411: Chemfort Female Luer Lock Adaptor (2025), 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/K141448
Methodology: https://510kreport.com/methodology