510(k) · Cleared
Recalled · 2006Optiv Antage DH Power Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Inc., Liebel-Flarsheim Business · DXT Injector And Syringe, Angiographic
Cleared on Nov 30, 2004 as substantially equivalent to K031339 (Mallinckrodt Inc., Liebel-Flarsheim Business, 2003) after a 57-day review. Its family tree reaches back 2 generations to 1992. 11 later devices descend from it. It has been recalled once.
- Decided
- Nov 30, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912944 (1992). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992 · Recalled
- 1 generation backK031339 OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003 · Recalled
- This deviceK042744 Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004
- Descendant · cites it directly · 7 of its ownK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK063503 Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business · 2007 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072886Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007 · cites it directly7descendants
- K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · 2 generations on5descendants
- K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 3 generations on4descendants
- K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 4 generations on3descendants
- K063503Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912944 | CT 8000 Digital Injection System | Mallinckrodt Group, Inc. | 1992 | 1 |
| −1 | K031339 | Optibolus | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003 | 1 |
| 0 (this device) | K042744 | Optiv Antage DH Power Injection System | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004 | — |
| +1 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
| +2 | K082905 | Medrad Stellant CT Injector System with P3T Cardiac | Medrad, Inc. | 2009 | 2 |
| +3 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| +4 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| +1 | K063503 | Optivantage DH Injector System with Enhanced Communication | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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.
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Nov 7, 2006 | Not classified | Z-0288-2007 | Other | The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K072886 (Medrad, Inc., 2007) has gone furthest, with 7 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.
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 OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042744: Optiv Antage DH Power 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/K042744
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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