# K894827: Automix 3+3 Compounder

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 6, 1989 after 67 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040456: Fleboset Multiple (2004), 11 descendants of its own
- K050339: Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple (2005), 6 descendants of its own
- K152441: KIRO Set (2015), 3 descendants of its own
- K082752: Quickpin (2008), 2 descendants of its own
- K170110: Diana Medication Transfer Set (2018), 1 descendant of its own

## Recalls of this device
- Jan 27, 2011 · Not classified · Z-1385-2011: 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

Source page: https://510kreport.com/device/K894827
Methodology: https://510kreport.com/methodology