# K972464: Vitalmix Plus Empty I.V. Container

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Device, Inc.
- Decided: Nov 5, 1997 after 127 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041038: Churchill Medical Dual Chamber Empty Container (2004), 5 descendants of its own
- K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container (2012), 3 descendants of its own
- K193528: Empty EVA Bag (2020), 2 descendants of its own
- K210749: Empty EVA Bag (2021), 1 descendant of its own
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own

## Indications for use
The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation “of drug admixtures of compatible medications.

Source page: https://510kreport.com/device/K972464
Methodology: https://510kreport.com/methodology