# K193010: Liebel-Flarsheim IBP Transfer Set

- Pathway: 510(k) (Traditional)
- Applicant: Liebel-Flarsheim Company, LLC
- Decided: Nov 18, 2020 after 386 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: 4 generations back to K791131 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161723: ulrich Transfer Set, Ulrich GmbH & Co. KG (2016) Summary page 4.

## Indications for use
The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (Ioversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container was penetrated, whichever occurs first. Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

Source page: https://510kreport.com/device/K193010
Methodology: https://510kreport.com/methodology