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Tevadaptor Closed Drug Reconstitution and Transfer System

by Migada Plant

510(k) K051669

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK051669 Date1 Sep 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1244-2009 FDA Unclassified (pre-2012) initiated 18 Dec 2008

    Syringe adaptor is disintegrating when attached to the end of the syringe.

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  • Withdrawn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
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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