# K090134: Intravenous Power Injector Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 21, 2009 after 90 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: 2 generations back to K960280 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980992: IV Administration Sets with Needleless Access Devices, Venetec Intl., Inc. (1998) Summary page 1.
- K061285: Smartsite Needle Free Valve Administration Sets, Cardinal Health, Alaris Products (2006) Summary page 1.

## Most influential descendants
- K093489: IN Vision-Plus Nano with Neutral Advantage Technology (2010), 0 descendants of its own

## Indications for use
The Intravenous Power Injector. Extension Set is intended to allow for the aspiration, injection or gravity/pump flow of fluids and may be used with low pressure power injectors having a maximum pressure setting of 325 psi and maximum flow rate of 10 ml/second. When used with a low pressure power injector, the Intravenous Power Injector Extension Set must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

Source page: https://510kreport.com/device/K090134
Methodology: https://510kreport.com/methodology