# K170110: Diana Medication Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Aug 10, 2018 after 575 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K903493 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050339: Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple, Laboratorios Grifols, S.A. (2005) Summary page 4.

## Most influential descendants
- K190157: Diana ChemoClave Transfer Set (2019), 0 descendants of its own

## Recalls of this device
- May 12, 2026 · Class II · Z-3161-2026: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber 

## Indications for use
The Diana ChemoLock 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/K170110
Methodology: https://510kreport.com/methodology