# K051669: Tevadaptor Closed Drug Reconstitution and Transfer System

- Pathway: 510(k) (Traditional)
- Applicant: Migada Plant
- Decided: Sep 1, 2005 after 71 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883614 (1988). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
2 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980381: Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro, Carmel Pharma Ab. (1998) Summary page 4.

## Most influential descendants
- K083152: Equashield System (2009), 9 descendants of its own
- K091389: Equalshield Luer Lock Connector Pair (2009), 8 descendants of its own
- K101940: Equashield System Protective Plus (2010), 7 descendants of its own
- K132899: Equashield Closed System Drug Transfer Device (CSTD) (2014), 6 descendants of its own
- K170706: Equashield Closed System drug Transfer Device (CSTD) (2017), 5 descendants of its own

## Recalls of this device
- Dec 18, 2008 · Not classified · Z-1244-2009: Syringe adaptor is disintegrating when attached to the end of the syringe.

## Indications for use
The TEVADAPTOR", Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

Source page: https://510kreport.com/device/K051669
Methodology: https://510kreport.com/methodology