# K131478: Contrast Conservation System

- Pathway: 510(k) (Traditional)
- Applicant: Osprey Medical, Inc.
- Decided: Aug 15, 2013 after 85 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: 4 generations back to K822536 (1982). 11 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993774: Acist Angiographic Injection System, Model CL1OOH, Acist Medical Systems (1999) Summary page 1.
- K991103: Modification to Acist CL 100H, Acist Medical Systems (2000) Summary page 1.
- K000013: Acist Angiographic Injection System, Model R-2000, Acist Medical Systems (2000) Summary page 1.
- K052744: C2000 Automated Manifold Kit, Acist Medical Systems, Inc. (2005) Summary page 1.
- K093830: Medline Angiographic Control Syringe, Medline Industries, Inc. (2011) Summary page 1.

## Most influential descendants
- K140425: Contrast Modulation System (2014), 12 descendants of its own
- K150485: AVERT Contrast Modulation System (2015), 10 descendants of its own
- K151300: AVERT Contrast Modulation System (2015), 8 descendants of its own
- K151746: Dyevert Contrast Modulation System (2015), 8 descendants of its own
- K153141: DyeVert Contrast Modulation System (2016), 7 descendants of its own

## Indications for use
The Osprey Medical AVERT Contrast Modulation System is intended to be used for the controlled infusion of radiopaque lodixanol 270 mg/mI contrast media for angiographic procedures.

Source page: https://510kreport.com/device/K131478
Methodology: https://510kreport.com/methodology