# K071741: Tevadaptor, Closed Drug Reconstitution and Transfer System

- Pathway: 510(k) (Traditional)
- Applicant: Migada Plant
- Decided: Sep 24, 2007 after 89 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.
11 later devices descend from it; 2 cite it directly.
0 of 17 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 2.

## Most influential descendants
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System (2015), 9 descendants of its own
- 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

## 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 M, Closed Drug Reconstitution and Transfer System is a closed 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/K071741
Methodology: https://510kreport.com/methodology