# K243985: Rio™ Drug Reconstitution Transfer Device

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Jan 22, 2025 after 30 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: 3 generations back to K900865 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192154: Rio Vial-to-Bag Drug Reconstitution Device, Icu Medical (2020) Summary page 5.

## Indications for use
Rio™ Drug Reconstitution Transfer Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

Source page: https://510kreport.com/device/K243985
Methodology: https://510kreport.com/methodology