# K161723: ulrich Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Dec 21, 2016 after 182 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.
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)
- K133147: Bracco Injeenering Transfer Set, Bracco Injeneering S.A. (2014) Summary page 4.

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

## Indications for use
The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

Source page: https://510kreport.com/device/K161723
Methodology: https://510kreport.com/methodology