# K050456: Medrad Avanta Fluid Management Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jun 17, 2005 after 114 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112086: Medrad Mark 7 Arterion  (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe (2011), 4 descendants of its own
- K113133: Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion Syringe (2011), 3 descendants of its own
- K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe (2014), 2 descendants of its own
- K193028: MEDRAD Mark 7 Arterion Injection System (2019), 0 descendants of its own
- K173450: PRESS DUO elite, PRESS DUO elite AG (2018), 0 descendants of its own

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2296-2026: Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably en
- Nov 5, 2012 · Class II · Z-0870-2013: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
- Jun 2, 2011 · Not classified · Z-2866-2011: Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complain
- Jan 6, 2010 · Not classified · Z-1199-2010: The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
- Sep 20, 2005 · Not classified · Z-0082-06: stress crack on the stopcock
- Sep 20, 2005 · Not classified · Z-0083-06: stress crack on the stopcock

## Indications for use
The MEDRAD Avanta Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.

Source page: https://510kreport.com/device/K050456
Methodology: https://510kreport.com/methodology