# K133147: Bracco Injeenering Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Bracco Injeneering S.A.
- Decided: Jun 20, 2014 after 246 days
- Product code: PQH (Iodinated Contrast Media Transfer Tubing Set)
- 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 K791131 (1979). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041178: Empower Transfer Set, (Cat. NO. 7725), E-Z-Em, Inc. (2004) Summary page 5.

## Most influential descendants
- 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
- K193010: Liebel-Flarsheim IBP Transfer Set (2020), 0 descendants of its own

## Indications for use
The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue {lopamido! Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringes on single-use only syringe-based contrast injection systems indicated for the controlled, aulomatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded aficr the contrast media container has been depleted or 10 hours has elapsed since the container was penetrated, whichever occurs first. )

Source page: https://510kreport.com/device/K133147
Methodology: https://510kreport.com/methodology