# K212530: IVX Fluid Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Omnicell, Inc.
- Decided: Apr 24, 2022 after 256 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: 6 generations back to K903493 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152441: KIRO Set, Kiro Robotics S.L. (2015) Summary page 4.

## Recalls of this device
- Feb 20, 2025 · Class II · Z-1532-2025: IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system cali

## Indications for use
The TVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System. The TVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications: * Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding, * aseptic reconstitution oflyophilized drug in vial(s) from an I.V. bag source and * aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration.

Source page: https://510kreport.com/device/K212530
Methodology: https://510kreport.com/methodology