# K041222: Pinnacle TPN Management System Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 14, 2004 after 157 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 K894827 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002705: Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400, Baxa Corp. (2001) Summary page 1.
- K961008: Automix 3+3/as Compounder System, Baxter Healthcare Corp (1997) Summary page 1.

## Indications for use
The Pinnacle Transfer Set is intended to be used with the Pinnacle TPN Management System gravimetric pharmacy compounding device in the pharmacy to provide a sterile fluid path for the compounding of ingredients from multiple source containers into a final container.

Source page: https://510kreport.com/device/K041222
Methodology: https://510kreport.com/methodology