# K050339: Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Feb 25, 2005 after 14 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: 4 generations back to K903493 (1991). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033682: Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube, Laboratorios Grifols, S.A. (2003) Summary page 1.
- K040456: Fleboset Multiple, Laboratorios Grifols, S.A. (2004) Summary page 1.

## Most influential descendants
- K152441: KIRO Set (2015), 3 descendants of its own
- K170110: Diana Medication Transfer Set (2018), 1 descendant of its own
- K212530: IVX Fluid Transfer Set (2022), 0 descendants of its own
- K203674: B Dispensing Line (2021), 0 descendants of its own
- K190157: Diana ChemoClave Transfer Set (2019), 0 descendants of its own

## Indications for use
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe. SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated I WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container. This device should not be used with lipids. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K050339
Methodology: https://510kreport.com/methodology