# K142527: Extension Set with BD Q-Syte Luer Access Split Septum

- Pathway: 510(k) (Traditional)
- Applicant: Acacia, Inc.
- Decided: Sep 19, 2014 after 11 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: 10 generations back to K001901 (2000). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090809: MPS Acacia Power Injectable Infusion Set, Mps Acacia (2009) Summary page 5.
- K895367: Intravenous Extension Set, Medical Product Specialists (1989) Summary page 5.
- K013621: BD Saf-T PRN Luer Activated Valve, Model 385100, Becton Dickinson Infusion Therapy Systems, Inc. (2002) Summary page 5.

## Most influential descendants
- K202672: Precision Delivery Infusion Set (2021), 0 descendants of its own

## Indications for use
Non-Power Injectable: Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused. Power Injectable: The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused. The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.

Source page: https://510kreport.com/device/K142527
Methodology: https://510kreport.com/methodology