# K093182: Set Gri-Fill 3.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Jan 27, 2010 after 111 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.
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)
- K082752: Quickpin, Laboratorios Grifols, S.A. (2008) Summary page 1.
- K040456: Fleboset Multiple, Laboratorios Grifols, S.A. (2004) Summary page 1.

## Most influential descendants
- K102590: Fleboset Double (2011), 0 descendants of its own

## Indications for use
SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 micron hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter. This device should not be used with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate and Diazepam. For information concerning compatibility of substances, please consult the information provided with the substance. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K093182
Methodology: https://510kreport.com/methodology