# K190157: Diana ChemoClave Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical
- Decided: Oct 23, 2019 after 266 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- 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: 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)
- K170110: Diana Medication Transfer Set, Icu Medical, Inc. (2018) Summary page 4.

## Indications for use
The Diana ChemoClave Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.

Source page: https://510kreport.com/device/K190157
Methodology: https://510kreport.com/methodology