510(k) · Cleared
Recalled · Class II · 2021Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. / Bayer Medical Care, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jan 23, 2014 as substantially equivalent to K113133 (Medrad, Inc., 2011) and 1 other predicate after a 127-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 23, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903390 (1990). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK903390 Medrad Mark V-Plus InjectorMedrad, Inc. · 1990 · Recalled
- 2 generations backK112086 Medrad Mark 7 Arterion (Pedestal System / Table Mount System)…Medrad, Inc. · 2011 · Recalled
- 1 generation backK113133 Medrad Mark 7 Arterion (Pedestal System), (Table Mount System)…Medrad, Inc. · 2011
- This deviceK132928 Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK193028 MEDRAD Mark 7 Arterion Injection SystemBayer Medical Care, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK173450 PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903390 | Medrad Mark V-Plus Injector | Medrad, Inc. | 1990 | 1 |
| −2 | K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | 1 |
| −1 | K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7… | Medrad, Inc. | 2011 | — |
| 0 (this device) | K132928 | Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe | Medrad, Inc. / Bayer Medical Care, Inc. | 2014 | — |
| +1 | K193028 | MEDRAD Mark 7 Arterion Injection System | Bayer Medical Care, Inc. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…Summary page 1…following devices: MEDRAD Mark 7 Arterion Injection System o K113133, December 15, 2011 to K1 12086, October 14, 2011 MIEDRAD, Inc. - MEDRA… | 2011 |
| * | K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…Summary page 1…MEDRAD Mark 7 Arterion Injection System o K113133, December 15, 2011 to K1 12086, October 14, 2011 MIEDRAD, Inc. - MEDRAD ma1 7 Arloo injection System 510(k) Summnary Page 1 of$ === Pag… | 2011 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Sep 14, 2021 | Class II | Z-0199-2022 | Packaging process control | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) |
| Aug 4, 2015 | Class II | Z-2775-2015 | Software design | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K193028 (Bayer Medical Care, Inc., 2019) has gone furthest, with 0 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. 2014, 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 injecting contrast medium and common flushing solutions into humans for angiographic studies.
The MEDRAD Mark 7 Arterion Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.
The MEDRAD Twist & Go Syringe, Quick Fill Tube and other MEDRAD supplied disposables are specifically intended for single use only with the MEDRAD Mark 7 Arterion Injection System for angiographic studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132928: Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132928
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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