# K133602: Add-Vantage Addaptor

- Pathway: 510(k) (Traditional)
- Applicant: Hospira, Inc.
- Decided: Jan 24, 2014 after 60 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 2 generations back to K900865 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090905: Addease 20MM Binary Connector with 17 GA. Needle, B.Braun Medical, Inc. (2009) Summary page 1.

## Indications for use
The ADD-Vantage ADDaptor 20 mm binary connector is a double ended transfer device intended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD-Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

Source page: https://510kreport.com/device/K133602
Methodology: https://510kreport.com/methodology