# K192370: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Dec 13, 2019 after 105 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K934086 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT, Bayer Medical Care, Inc. (2018) Summary page 4.

## Recalls of this device
- Oct 5, 2020 · Class II · Z-0483-2021: Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

## Indications for use
The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling and to the device labeling for information relating to “imaging agent”.

Source page: https://510kreport.com/device/K192370
Methodology: https://510kreport.com/methodology