# K103165: Blood Sampling Set

- Pathway: 510(k) (Traditional)
- Applicant: Acacia, Inc.
- Decided: Nov 10, 2010 after 14 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: 3 generations back to K862691 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock, Elcam Medical Acal (2006) Summary page 1.
- K895367: Intravenous Extension Set, Medical Product Specialists (1989) Summary page 1.

## Indications for use
The Blood Sampling Set is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Source page: https://510kreport.com/device/K103165
Methodology: https://510kreport.com/methodology