# K033682: Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Dec 17, 2003 after 23 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Exacta-Mix Set: named in the summary without a submission number
- (no number) Baxter transfer sets presented together with compounder: named in the summary without a submission number

## Most influential descendants
- K050339: Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple (2005), 6 descendants of its own
- 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

## Indications for use
All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospital pharmacy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician.

Source page: https://510kreport.com/device/K033682
Methodology: https://510kreport.com/methodology