# K092318: Baxject II HI-Flow Needleless Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 30, 2009 after 87 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 K001831 (2000). 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)
- K042410: Baxject II, Baxter Healthcare Corp (2004) Summary page 2.
- K001831: Needleless Transfer Device, Medimop Medical Projects, Ltd. (2000) Summary page 2.

## Indications for use
The BAXJECT II Hi-Flow Needleless Transfer Device is intended for transferring and mixing of drugs contained in two vials into a syringe.

Source page: https://510kreport.com/device/K092318
Methodology: https://510kreport.com/methodology