# K955398: Formulation Preparation Device

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 4, 1996 after 132 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 K792227 (1979). 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)
- K792227: Multi-AD Fluid Dispensing System, National Patent Development Corp. (1979) Summary page 1.

## Indications for use
The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.

Source page: https://510kreport.com/device/K955398
Methodology: https://510kreport.com/methodology