# K203738: Qitexio

- Pathway: 510(k) (Traditional)
- Applicant: Medex
- Decided: Mar 14, 2022 after 447 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K980580 (1998). 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)
- K173601: Merit Syringe, Merit Medical Systems, Inc. (2018) Summary page 4.

## Indications for use
Qitexio Luer Lock Syringes are manual devices used to inject fluids into the body. They are also used for delivery of Lipiodol (Ethiodized Oil) Injection.

Source page: https://510kreport.com/device/K203738
Methodology: https://510kreport.com/methodology