510(k) · Cleared
ClearedOptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liebel-Flarsheim Company, LLC · IZQ Injector, Contrast Medium, Automatic
Cleared on Jan 14, 2016 as substantially equivalent to K063503 (Mallinckrodt Inc., Liebel-Flarsheim Business, 2007) after a 147-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jan 14, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912944 (1992). 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 deviceK152361 OptiOne Single-Head Contrast Delivery System with Pedestal; with…Liebel-Flarsheim Company, LLC · 2016
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) | K152361 | OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling… | Liebel-Flarsheim Company, LLC | 2016 | — |
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 |
|---|---|---|---|
| * | K063503 | Optivantage DH Injector System with Enhanced CommunicationSummary page 4…S8473 Suspension III. PREDICATE DEVICE OptiVantage DH Injector System with Enhanced Communication (K063503) IV. DEVICE DESCRIPTION: The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque… | 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 24 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 4 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K063503.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 OptiOne Single-Head Contrast Delivery 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/K152361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152361: OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152361
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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