510(k) · Cleared
ClearedMR Syringe Dual Pack for Solaris Injectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coeur, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Oct 6, 2016 as substantially equivalent to K033247 (Medrad, Inc., 2003) after a 132-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Oct 6, 2016
- Review
- 132 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K012950 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK012950 Modification to: Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2001
- 1 generation backK033247 Medrad Spectris Solaris MR Injector SystemMedrad, Inc. · 2003
- This deviceK161471 MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK170431 CT Syringe for Stellant Injectors (with & without Spikes, Prime…Coeur, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K012950 | Modification to: Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2001 | — |
| −1 | K033247 | Medrad Spectris Solaris MR Injector System | Medrad, Inc. | 2003 | — |
| 0 (this device) | K161471 | MR Syringe Dual Pack for Solaris Injectors | Coeur, Inc. | 2016 | — |
| +1 | K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill… | Coeur, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K033247 | Medrad Spectris Solaris MR Injector SystemSummary page 4…lly Marketed Devices to which Substantial Equivalence is claimed: Primary Predicate Device Medrad: Syringe Included in Spectris Solaris MR Injection System (K033247) Referenced Devices Coeur: Coeur 130mL Syringe (K971712) Coeur Syringes for Nemoto Injectors… | 2003 |
| † | K971712 | Coeur 130 ML Angiographic Syringe | 1997 |
| † | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | 2005 |
| † | K120892 | Disposable 330PSI Extension Lines | 2013 |
| † | K140469 | MR Syringe Dual Pack | 2014 |
| † | K062449 | Empowermr Injector System, Model 9730 | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT… | 2017 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K170431 (Coeur, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033247.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
For use with the Medrad Spectris® Solaris™ MR Injection System for the injection of contrast media or saline to the vascular system for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161471 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161471: MR Syringe Dual Pack for Solaris Injectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161471
Report an extraction error
Are you the manufacturer?
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