# K090809: MPS Acacia Power Injectable Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Mps Acacia
- Decided: Apr 28, 2009 after 34 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: 9 generations back to K001901 (2000). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032934: MPS Acacia Safeguard Huber Device, Mps Acacia (2003) Summary page 1.
- K073050: Safestep Max Power-Injectable Infusion Set, Specialized Health Products International, Inc. (2008) Summary page 1.
- K083472: Medegen Pressure Rated Extension Sets, Medegen, Inc. (2008) Summary page 1.

## Most influential descendants
- 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 Power Injectable Infusion Set with Huber Needle is indicated for: Use with implanted infusion ports for continuous or intermittent infusion therapy. Infusion or withdrawal of IVfluids, blood, blood products, or drugs. Use with ports that are indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5mL/sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles. Power injection of contrast media up to 325 PSI. The Power Injectable Infusion Set with male luer lock is indicated for: Use with central venous catheters for continuous or intermittent infusion therapy. Infusion or withdrawal of IVfluids, blood, blood products, or drugs. Use with central venous catheters that are indicated for power injection of contrast media into the central venous system. Power injection of contrast media up to 325 PSI.

Source page: https://510kreport.com/device/K090809
Methodology: https://510kreport.com/methodology