# K961008: Automix 3+3/as Compounder System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 10, 1997 after 577 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894827 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894827: Automix 3+3 Compounder, Baxter Healthcare Corp (1989) Summary page 1.

## Most influential descendants
- K041222: Pinnacle TPN Management System Transfer Set (2004), 0 descendants of its own

## Recalls of this device
- Jan 27, 2011 · Not classified · Z-1386-2011: The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when e

## Indications for use
This device is an electromechanical positive displacement fluid compounding device that provides for the compounding of fluids via gravimetric weighing.

Source page: https://510kreport.com/device/K961008
Methodology: https://510kreport.com/methodology