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TEVADAPTOR Closed Drug Reconstitution and Transfer System

by Teva Medical Ltd., Migada Plant 3 variants

510(k) K141448

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK141448 Date23 Jan 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ONB
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

The system is supplied by Teva Medical Ltd., Migada Plant and has received FDA 510(k) clearance with the product code ONB. It is designed for use in general hospital settings for handling antineoplastic and hazardous drugs. The device is classified as a Class II medical device and is intended to provide a closed system for drug reconstitution and transfer procedures.

Other devices from Teva Medical Ltd., Migada Plant

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TEVADAPTOR system designed for?

    The TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) designed to mechanically prevent the release of drugs in vapor, aerosol or liquid form during preparation and administration, minimizing exposure to hazardous drugs.

  • How is the TEVADAPTOR system supplied?

    The TEVADAPTOR system is supplied by Teva Medical Ltd., Migada Plant and is designed for use in general hospital settings for handling antineoplastic and hazardous drugs.

  • What regulatory clearance has the TEVADAPTOR received?

    The TEVADAPTOR has received FDA 510(k) clearance with the product code ONB and is classified as a Class II medical device, providing a closed system for drug reconstitution and transfer procedures.

  • What environments is the TEVADAPTOR intended for?

    The TEVADAPTOR is intended for use in general hospital settings for handling antineoplastic and hazardous drugs, designed to prevent the introduction of microbial and airborne contaminants into the drug path.