510(k) · Cleared
ClearedMEDRAD Mark 7 Arterion Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Medical Care, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Dec 5, 2019 as substantially equivalent to K132928 (Medrad, Inc. / Bayer Medical Care, Inc., 2014) after a 36-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Dec 5, 2019
- Review
- 36 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903390 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK903390 Medrad Mark V-Plus InjectorMedrad, Inc. · 1990 · Recalled
- 3 generations backK112086 Medrad Mark 7 Arterion (Pedestal System / Table Mount System)…Medrad, Inc. · 2011 · Recalled
- 2 generations backK113133 Medrad Mark 7 Arterion (Pedestal System), (Table Mount System)…Medrad, Inc. · 2011
- 1 generation backK132928 Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014 · Recalled
- This deviceK193028 MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903390 | Medrad Mark V-Plus Injector | Medrad, Inc. | 1990 | 1 |
| −3 | 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 | — |
| −1 | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe | Medrad, Inc. / Bayer Medical Care, Inc. | 2014 | 2 |
| 0 (this device) | K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeSummary page 4…equivalent to the following device: MEDRAD® Mark 7 Arterion Injection System, K132928. Bayer Medical Care Inc. MEDRAD Mark 7 Arterion Injection System 510(k) Summary Page 1 of 6… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K132928.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
MEDRAD® Mark 7 Arterion Injection System
The MEDRAD® Mark 7 Arterion Injection System is indicated to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Imaging System Interface (ISI)
The ISI option is indicated for the specific purpose of allowing a MEDRAD® Mark 7 Arterion Injection System to interface with an angiography imaging system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193028 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193028: MEDRAD Mark 7 Arterion Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193028
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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