510(k) · Cleared
Recalled · Class II · 2020MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Medical Care, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Dec 13, 2019 as substantially equivalent to K182273 (Bayer Medical Care, Inc., 2018) after a 105-day review. Its family tree reaches back 8 generations to 1995. It has been recalled once.
- Decided
- Dec 13, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K934086 (1995). 12 ancestors in all, the oldest K912944 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 7 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 6 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 5 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 4 generations backK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
- 3 generations backK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
- 2 generations backK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- 1 generation backK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- This deviceK192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −7 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −6 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −5 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −4 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
| −3 | K082905 | Medrad Stellant CT Injector System with P3T Cardiac | Medrad, Inc. | 2009 | 2 |
| −2 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| −1 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| 0 (this device) | K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Summary page 4…CFR Part 870.1650, Angiographic injector and syringe Predicate Device: MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, K182273 Device Description: The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation is a software- controlled power in… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2020 | Class II | Z-0483-2021 | Process control | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K182273.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous imaging agents, including saline, into humans for diagnostic studies in computed tomography (CT) and mammography. For complete prescribing information, refer both to the current drug labeling and to the device labeling for information relating to “imaging agent”.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192370: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192370
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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