# K040456: Fleboset Multiple

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Mar 9, 2004 after 15 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: 3 generations back to K903493 (1991). 4 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894827: Automix 3+3 Compounder, Baxter Healthcare Corp (1989) Summary page 2.
- K022431: Medrad Transfer Set, Medrad, Inc. (2002) Summary page 2.
- K961794: Fluid Administration Set - Contrast Manager, Merit Medical Systems, Inc. (1996) Summary page 2.

## 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
- K082752: Quickpin (2008), 2 descendants of its own
- K170110: Diana Medication Transfer Set (2018), 1 descendant of its own
- K093182: Set Gri-Fill 3.0 (2010), 1 descendant of its own

## Indications for use
FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for: (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set. The 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 order of a physician.

Source page: https://510kreport.com/device/K040456
Methodology: https://510kreport.com/methodology