# K102590: Fleboset Double

- Pathway: 510(k) (Abbreviated)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Jan 13, 2011 after 126 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: 6 generations back to K903493 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093182: Set Gri-Fill 3.0, Laboratorios Grifols, S.A. (2010) Summary page 1.
- K040456: Fleboset Multiple, Laboratorios Grifols, S.A. (2004) Summary page 1.

## Indications for use
Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and b) Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy compounding device and associated transfer sets. Equipped with a spike on each line and a 0.2 jam 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. Set tubing is PVC with DEHP plasticizer. Do not use 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, Diazepam. For information concerning compatibility of substances, please consult the information provided by the manufacturer. 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/K102590
Methodology: https://510kreport.com/methodology