510(k) · Cleared
ClearedMEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
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 Feb 13, 2026 as substantially equivalent to K182276 (Bayer Medical Care, Inc., 2018) after a 155-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Feb 13, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K012950 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
- 4 generations backK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
- 3 generations backK042784 Medrad Spectris Solaris EP MR Injector SystemMedrad, Inc. · 2004
- 2 generations backK143538 MRXperion MR Injection System, MRXperion MR Injection System Syringe…Bayer Medical Care, Inc. · 2015 · Recalled
- 1 generation backK182276 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2018
- This deviceK252891 MEDRAD MRXperion MR Injection System and MR Injection System Syringe…Bayer Medical Care, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012950 | Modification to: Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2001 | — |
| −4 | K033247 | Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2003 | — |
| −3 | K042784 | Medrad Spectris Solaris EP MR Injector System | Medrad, Inc. | 2004 | — |
| −2 | K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2015 | 1 |
| −1 | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. | 2018 | — |
| 0 (this device) | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit… | Bayer Medical Care, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitSummary page 5…e of Device: MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit 510(k) Number: K182276 Common Name: Angiographic Injector and Syringe Classification Name: Injector and Syringe, A… | 2018 |
| † | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient… | 2024 |
| † | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | 2021 |
| † | K210611 | MAGNETOM Free.Max | 2021 |
| † | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | 2024 |
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 25 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media and saline during MR procedures. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications. Only trained healthcare professionals are intended to operate this device. For a complete…
Read the full statement (110 words)
The MEDRAD® MRXperion MR Injection System is a syringe-based fluid delivery system indicated for delivery of
contrast media and saline during MR procedures. It is intended to be used for the specific purpose of injecting intravenous
MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI)
applications. Only trained healthcare professionals are intended to operate this device.
For a complete list of compatible contrast agents for use with the MEDRAD® MRXperion MR Injection System, refer to
the MRXperion MR Injection System operation manual.
The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252891: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252891
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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