# K192154: Rio Vial-to-Bag Drug Reconstitution Device

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical
- Decided: Apr 20, 2020 after 255 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: 2 generations back to K900865 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090905: Addease 20MM Binary Connector with 17 GA. Needle, B.Braun Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K243985: Rio™ Drug Reconstitution Transfer Device (2025), 0 descendants of its own

## Indications for use
Rio™ Vial-to-Bag Drug Reconstitution 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/K192154
Methodology: https://510kreport.com/methodology