# K032934: MPS Acacia Safeguard Huber Device

- Pathway: 510(k) (Traditional)
- Applicant: Mps Acacia
- Decided: Nov 13, 2003 after 52 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 K890127 (1989). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982047: MPS Huber Needle Extension Set, Medical Product Specialists (1998) Summary page 1.
- K993848: Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. (2000) Summary page 1.
- K021565: Luther Safety Huber Needle Set, Luther Research Partners (2002)
- K013871: Lifeguard Safety Infusion Set, Horizon Medical Products, Inc. (2002)

## Most influential descendants
- K090809: MPS Acacia Power Injectable Infusion Set (2009), 2 descendants of its own
- K142527: Extension Set with BD Q-Syte Luer Access Split Septum (2014), 1 descendant of its own
- K202672: Precision Delivery Infusion Set (2021), 0 descendants of its own

## Indications for use
The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.

Source page: https://510kreport.com/device/K032934
Methodology: https://510kreport.com/methodology