# K041178: Empower Transfer Set, (Cat. NO. 7725)

- Pathway: 510(k) (Traditional)
- Applicant: E-Z-Em, Inc.
- Decided: Jul 16, 2004 after 72 days
- Product code: FPK (Tubing, Fluid Delivery)
- 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: 1 generation back to K791131 (1979). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791131: Flu Ven TR-1, Venospital, Inc. (1979) Summary page 1.

## Most influential descendants
- K133147: Bracco Injeenering Transfer Set (2014), 5 descendants of its own
- K173913: MEDRAD® Imaging Bulk Package Transfer Set (2018), 2 descendants of its own
- K200280: MEDRAD Imaging Bulk Package Transfer Spike (2020), 1 descendant of its own
- K161723: ulrich Transfer Set (2016), 1 descendant of its own
- K253688: MEDRAD® Imaging Bulk Package Transfer Spike (2026), 0 descendants of its own

## Indications for use
The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

Source page: https://510kreport.com/device/K041178
Methodology: https://510kreport.com/methodology