510(k) · Cleared
ClearedCoeur, Inc. Frontload for Optivantage Power Injector
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 Apr 30, 2014 as substantially equivalent to K070798 (Coeur, Inc., 2007) and 2 other predicates after a 156-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Apr 30, 2014
- Review
- 156 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K912944 (1992). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992 · Recalled
- 3 generations backK031339 OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003 · Recalled
- 2 generations backK042744 Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · Recalled
- 1 generation backK063503 Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business · 2007 · Recalled
- This deviceK133600 Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912944 | CT 8000 Digital Injection System | Mallinckrodt Group, Inc. | 1992 | 1 |
| −3 | K031339 | Optibolus | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003 | 1 |
| −2 | K042744 | Optiv Antage DH Power Injection System | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004 | 1 |
| −1 | K063503 | Optivantage DH Injector System with Enhanced Communication | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007 | 1 |
| 0 (this device) | K133600 | Coeur, Inc. Frontload for Optivantage Power Injector | Coeur, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070798 | Adapters for CT, Angiographic, and/or Mri Power Injectors | 2007 |
| * | K993728 | Medrad Envision CT Injector SystemSummary page 1…Equivalence is claimed: Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors (KO70798) - Coeur Medrad Envision CT Injector System, Medrad, K993728 Optivantage DH Injector System with Enhanced Communication (K063503)- Mallickrodt Inc., Liebel-Flarsheim Device Description: Th… | 1999 |
| * | K063503 | Optivantage DH Injector System with Enhanced CommunicationSummary page 1…T and/or Angiographic Power Injectors (KO70798) - Coeur Medrad Envision CT Injector System, Medrad, K993728 Optivantage DH Injector System with Enhanced Communication (K063503)- Mallickrodt Inc., Liebel-Flarsheim Device Description: The proposed device is a Front Load Adapterfor Liebel- Flarsheim Optiva… | 2007 |
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 22 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K070798.
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?
For use in adapting Liebel-Elarsheim Optivantage DH Injectors for use with Coeur Front load Syringes
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/K133600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133600: Coeur, Inc. Frontload for Optivantage Power Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133600
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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