510(k) · Cleared
Recalled · 2008Optivantage DH Injector System with Enhanced Communication
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Inc., Liebel-Flarsheim Business · IZQ Injector, Contrast Medium, Automatic
Cleared on Apr 27, 2007 as substantially equivalent to K042744 (Mallinckrodt Inc., Liebel-Flarsheim Business, 2004) after a 158-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 27, 2007
- Review
- 158 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912944 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK912944 CT 8000 Digital Injection SystemMallinckrodt Group, Inc. · 1992 · Recalled
- 2 generations backK031339 OptibolusMallinckrodt Inc., Liebel-Flarsheim Business · 2003 · Recalled
- 1 generation backK042744 Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business · 2004 · Recalled
- This deviceK063503 Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business · 2007
- Descendant · cites it directly · 0 of its ownK152361 OptiOne Single-Head Contrast Delivery System with Pedestal; with…Liebel-Flarsheim Company, LLC · 2016
- Descendant · cites it directly · 0 of its ownK133600 Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc. · 2014
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 | K912944 | CT 8000 Digital Injection System | Mallinckrodt Group, Inc. | 1992 | 1 |
| −2 | K031339 | Optibolus | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003 | 1 |
| −1 | K042744 | Optiv Antage DH Power Injection System | Mallinckrodt Inc., Liebel-Flarsheim Business | 2004 | 1 |
| 0 (this device) | K063503 | Optivantage DH Injector System with Enhanced Communication | Mallinckrodt Inc., Liebel-Flarsheim Business | 2007 | — |
| +1 | K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling… | Liebel-Flarsheim Company, LLC | 2016 | — |
| +1 | K133600 | Coeur, Inc. Frontload for Optivantage Power Injector | Coeur, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 IZQ? 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 IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 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 |
|---|---|---|---|
| * | K042744 | Optiv Antage DH Power Injection SystemSummary page 2…al Equivalence The predicate injector to the OptiVantage DH Injector System with Enhanced Communication is the OptiVantage DH Power Injection System, 510(k) number K042744. The OptiVantage DH Injector System with Enhanced Communication maintains the same intended use as the predicate device. I… | 2004 |
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 |
|---|---|---|---|---|
| Apr 7, 2008 | Not classified | Z-1694-2008 | Component design/selection | Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff. |
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 2.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K152361 (Liebel-Flarsheim Company, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042744.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, 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 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OptiVantage DH Injector System with Enhanced Communication 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/K063503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063503: Optivantage DH Injector System with Enhanced Communication.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063503
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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