510(k) · Cleared
Recalled · Class II · 2018Medrad Stellant CT Injector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jan 10, 2003 as substantially equivalent to K934086 (Medrad, Inc., 1995) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 1995. 36 later devices descend from it. It has been recalled 6 times.
- Decided
- Jan 10, 2003
- Review
- 108 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934086 (1995). 36 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 1 generation backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- This deviceK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- Descendant · 3 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
- Descendant · 4 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
- Descendant · 2 generations on · 7 of its ownK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc. · 2004 · cites it directly34descendants
- K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · 2 generations on18descendants
- K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 3 generations on15descendants
- K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 4 generations on8descendants
- K072886Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −1 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| 0 (this device) | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | — |
| +1 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| +2 | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | Coeur, Inc. | 2005 | — |
| +3 | K072696 | Ant Angiographic Syringes, Model (S)… | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008 | — |
| +4 | K151960 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Baoan Medical Supplies Co., Ltd. | 2016 | — |
| +2 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K934086 | Medrad Envision CT Injector and Qwik Fit SyringeSummary page 1…ngiographic Predicate Device: Medrad Envision CT Injector System K934086andK993728 Substantial Equivalence: The information provided in this premarket notification demonstrates dedrad. I… | 1995 |
| * | K993728 | Medrad Envision CT Injector SystemSummary page 1…c Predicate Device: Medrad Envision CT Injector System K934086andK993728 Substantial Equivalence: The information provided in this premarket notification demonstrates dedrad. Inc. that… | 1999 |
What descends from it? (36)
See all 363 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 |
|---|---|---|---|---|
| Dec 14, 2018 | Class II | Z-0745-2019 | Device Design | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. |
| Oct 24, 2011 | Not classified | Z-0147-2012 | Packaging | Packaging may exhibit open seals - sterility compromised |
| May 24, 2010 | Not classified | Z-1954-2010 | Other | Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury. |
| Oct 10, 2005 | Not classified | Z-0154-06 | Other | the heat maintainer, an accessory, may overheat and deform the disposable syringe |
| Nov 3, 2004 | Not classified | Z-0257-05 | Other | Sterility can be compromised by a tear in the outer packaging. |
| Oct 8, 2004 | Not classified | Z-0039-05 | Other | Sterility can be compromised by a component tearing the outer packaging |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033881 (Medrad, Inc., 2004) has gone furthest, with 34 descendants of its own.
- 3 other devices also cite its predicate K934086.
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 Medrad Stellant CT Injector System is intended for the specific purpose of injecting
intravenous contrast media into humans for diagnostic studies in computed tomography (CT)
applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023183: Medrad Stellant CT Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023183
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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