# K103562: Centurion Pressure Injectable Extension Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Centurion Medical Products Corporation
- Decided: Jun 23, 2011 after 199 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960280 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061285: Smartsite Needle Free Valve Administration Sets, Cardinal Health, Alaris Products (2006) Summary page 1.

## Most influential descendants
- K141285: Busse Extension Set (2015), 0 descendants of its own

## Recalls of this device
- Jun 21, 2006 · Not classified · Z-1253-06: The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.

## Indications for use
The Centurion® Pressure Injectable Extension Set is an IV extension set intended for the delivery and/or aspiration of fluids and may be used in conjunction with power injectors having a maximum pressure setting of 325 psi and a maximum flow rate of 10 niL/second.

Source page: https://510kreport.com/device/K103562
Methodology: https://510kreport.com/methodology