510(k) · Cleared
Recalled · Class II · 2026MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
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 Nov 1, 2018 as substantially equivalent to K173773 (Bayer Medical Care, Inc., 2018) after a 71-day review. Its family tree reaches back 7 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 2018
- Review
- 71 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K934086 (1995). 11 ancestors in all, the oldest K912944 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 6 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 5 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 4 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 3 generations backK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
- 2 generations backK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
- 1 generation backK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- This deviceK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
- Descendant · 2 generations on · 0 of its ownK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
- Descendant · cites it directly · 0 of its ownK192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K210541ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021 · cites it directly1descendant
- K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025 · 2 generations on0descendants
- K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −6 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −5 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −4 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −3 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
| −2 | K082905 | Medrad Stellant CT Injector System with P3T Cardiac | Medrad, Inc. | 2009 | 2 |
| −1 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| 0 (this device) | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | — |
| +1 | K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021 | — |
| +2 | K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025 | — |
| +1 | K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | Bayer Medical Care, Inc. | 2019 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Summary page 5…devices: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, K173773 MEDRAD Stellant CT Injector System with Certegra Workstation,… | 2018 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Jul 31, 2026 | Class II | Z-3147-2026 | Employee error | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K210541 (Ulrich GmbH & Co. KG, 2021) has gone furthest, with 1 descendant 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. 2018, 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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the…
Read the full statement (283 words)
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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
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 contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.
P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.
P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).
The ISI module option is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182273 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182273: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182273
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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