# K152441: KIRO Set

- Pathway: 510(k) (Traditional)
- Applicant: Kiro Robotics S.L.
- Decided: Dec 4, 2015 after 99 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: 5 generations back to K903493 (1991). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 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
- K212530: IVX Fluid Transfer Set (2022), 0 descendants of its own
- K203674: B Dispensing Line (2021), 0 descendants of its own
- K162216: Gri-Fill Peristaltic Set (2017), 0 descendants of its own

## Indications for use
The KIRO Set is a sterile, single-use disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.

Source page: https://510kreport.com/device/K152441
Methodology: https://510kreport.com/methodology