# K173913: MEDRAD® Imaging Bulk Package Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Bayer U.S., LLC
- Decided: May 4, 2018 after 133 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: 3 generations back to K791131 (1979). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133147: Bracco Injeenering Transfer Set, Bracco Injeneering S.A. (2014) Summary page 4.

## Most influential descendants
- K200280: MEDRAD Imaging Bulk Package Transfer Spike (2020), 1 descendant of its own
- K253688: MEDRAD® Imaging Bulk Package Transfer Spike (2026), 0 descendants of its own

## Indications for use
The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.

Source page: https://510kreport.com/device/K173913
Methodology: https://510kreport.com/methodology