# K082027: Flu-Admin, Models 60150, 60150C, 60151C, 60153C, 60160

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Bps, LLC
- Decided: Feb 13, 2009 after 211 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 1 generation back to K843692 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K843692: Flu Ven I.V. Set 0153-C Perma-Set, Venusa, Ltd. (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- K081914: Flu Ven I.V. Sets. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Genesis BPS FLU-ADMIN I.V. Sets are intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter into a vein.

Source page: https://510kreport.com/device/K082027
Methodology: https://510kreport.com/methodology
