510(k) · Cleared
Recalled · Class II · 2018Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe
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 Oct 14, 2011 as substantially equivalent to K903390 (Medrad, Inc., 1990) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 14, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903390 (1990). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903390 Medrad Mark V-Plus InjectorMedrad, Inc. · 1990 · Recalled
- This deviceK112086 Medrad Mark 7 Arterion (Pedestal System / Table Mount System)…Medrad, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK113133 Medrad Mark 7 Arterion (Pedestal System), (Table Mount System)…Medrad, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK132928 Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK193028 MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…Medrad, Inc. · 2011 · cites it directly3descendants
- K132928Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · cites it directly2descendants
- K193028MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019 · 2 generations on0descendants
- K173450PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903390 | Medrad Mark V-Plus Injector | Medrad, Inc. | 1990 | 1 |
| 0 (this device) | K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | — |
| +1 | K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | — |
| +1 | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe | Medrad, Inc. / Bayer Medical Care, Inc. | 2014 | 2 |
| +2 | K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019 | — |
| +2 | K173450 | PRESS DUO elite, PRESS DUO elite AG | Nemoto Kyorindo Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903390 | Medrad Mark V-Plus InjectorSummary page 1…Device(s): The subject device is equivalent to the following devices: * MEDRAD Mark V Provis Injection System (NFJ) * K(903390 MEDRAD Mark V Plus Injection System * K050456 MEDRAD Avanta Hluid Management System Device Description:… | 1990 |
| * | K050456 | Medrad Avanta Fluid Management Injection SystemSummary page 1…s: * MEDRAD Mark V Provis Injection System (NFJ) * K(903390 MEDRAD Mark V Plus Injection System * K050456 MEDRAD Avanta Hluid Management System Device Description: The MEDRAD Arterion Mark 7 is a software controlled medical… | 2005 |
| * | — | MEDRAD Mark V Provis Injection System Named without a submission number |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Dec 14, 2018 | Class II | Z-0745-2019 | Device Design | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injectina contrast mnediumn and common flushing solutions into humans for angiographic studies.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112086: Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112086
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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