# K120150: Dual Spike Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: May 24, 2012 after 127 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: 1 generation back to K925401 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925401: IV Fluid Transfer Pin, B. Braun of America, Inc. (1993) Summary page 1.

## Indications for use
The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.

Source page: https://510kreport.com/device/K120150
Methodology: https://510kreport.com/methodology