# K031419: Gri-Flex, Models 1000ML, 500ML, 250ML, 100ML

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Nov 24, 2003 after 203 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) VIAFLEX Plastic Container (Baxter): named in the summary without a submission number
- (no number) Pall SUPOR AEF: named in the summary without a submission number

## Indications for use
All models of GRI-FLEX are flexible I.V. bags, with incorporated 0.2 pm filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on order of a physician.

Source page: https://510kreport.com/device/K031419
Methodology: https://510kreport.com/methodology