510(k) · Cleared
Recalled · Class II · 2026Medrad Avanta Fluid Management Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jun 17, 2005 after a 114-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 17, 2005
- Review
- 114 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 6
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK050456 Medrad Avanta Fluid Management Injection SystemMedrad, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK112086 Medrad Mark 7 Arterion (Pedestal System / Table Mount System)…Medrad, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK113133 Medrad Mark 7 Arterion (Pedestal System), (Table Mount System)…Medrad, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK132928 Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK193028 MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112086Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc. · 2011 · cites it directly4descendants
- K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc. · 2011 · 2 generations on3descendants
- K132928Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · 2 generations on2descendants
- K193028MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019 · 3 generations on0descendants
- K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050456 | Medrad Avanta Fluid Management Injection System | Medrad, Inc. | 2005 | — |
| +1 | K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | 1 |
| +2 | K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | — |
| +2 | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe | Medrad, Inc. / Bayer Medical Care, Inc. | 2014 | 2 |
| +3 | K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019 | — |
| +3 | K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2026 | Class II | Z-2296-2026 | Process control | 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 engaged with the CFCV snap interface. In… |
| Nov 5, 2012 | Class II | Z-0870-2013 | Packaging | 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 | Device Design | 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 complaints and adverse event reporting… |
| Jan 6, 2010 | Not classified | Z-1199-2010 | Nonconforming Material/Component | 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 | Other | stress crack on the stopcock |
| Sep 20, 2005 | Not classified | Z-0083-06 | Other | stress crack on the stopcock |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112086 (Medrad, Inc., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050456: Medrad Avanta Fluid Management Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026