# K152218: AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical
- Decided: Sep 21, 2015 after 45 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K822536 (1982). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140425: Contrast Modulation System, Osprey Medical, Inc. (2014) Summary page 5.
- K150485: AVERT Contrast Modulation System, Osprey Medical, Inc. (2015) Summary page 5.

## Indications for use
The AVERT™ Contrast Modulation System is to be used for the controlled infusion of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL, Iopamidol 300 or 370 mgI/mL and Ioxilan 350mgI/mL.

Source page: https://510kreport.com/device/K152218
Methodology: https://510kreport.com/methodology