# K120375: Med-RX Patient Delivery Set

- Pathway: 510(k) (Traditional)
- Applicant: Benlan, Inc.
- Decided: Jun 28, 2012 after 143 days
- Product code: FPA (Set, Administration, Intravascular)
- 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 K935668 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984088: Optistar MR Injector System, Mallinckrodt Inc., Liebel-Flarsheim Business (1999) Summary page 1.

## Indications for use
The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images.

Source page: https://510kreport.com/device/K120375
Methodology: https://510kreport.com/methodology