510(k) · Cleared
ClearedMedrad Envision CT Injector and Qwik Fit Syringe
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 Jun 15, 1995 after a 660-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 52 later devices descend from it.
- Decided
- Jun 15, 1995
- Review
- 660 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 4 citing it directly.
- This deviceK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- Descendant · cites it directly · 39 of its ownK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- Descendant · cites it directly · 36 of its ownK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 34 of its ownK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- Descendant · 4 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K993728Medrad Envision CT Injector SystemMedrad, Inc. · 1999 · cites it directly39descendants
- K023183Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · cites it directly36descendants
- K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc. · 2004 · 2 generations on34descendants
- K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · 3 generations on18descendants
- K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| +1 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| +1 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| +2 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| +3 | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | Coeur, Inc. | 2005 | — |
| +4 | K072696 | Ant Angiographic Syringes, Model (S)… | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (52)
See all 524 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993728 (Medrad, Inc., 1999) has gone furthest, with 39 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 | — |
https://510kreport.com/device/K934086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934086: Medrad Envision CT Injector and Qwik Fit Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934086
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026