510(k) · Cleared
Recalled · Class II · 2016Medrad Stellant CT Injector System with P3T Cardiac
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 12, 2009 as substantially equivalent to K072886 (Medrad, Inc., 2007) after a 104-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 12, 2009
- Review
- 104 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934086 (1995). 8 ancestors in all, the oldest K912944 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 4 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 3 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 2 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 1 generation backK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
- This deviceK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 1 of its ownK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
- Descendant · 4 generations on · 0 of its ownK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
- Descendant · 3 generations on · 0 of its ownK192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · cites it directly4descendants
- K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 2 generations on3descendants
- K210541ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021 · 3 generations on1descendant
- K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025 · 4 generations on0descendants
- K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −4 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −3 | 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 |
| −1 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
| 0 (this device) | K082905 | Medrad Stellant CT Injector System with P3T Cardiac | Medrad, Inc. | 2009 | — |
| +1 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| +2 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD… | Bayer Medical Care, Inc. | 2018 | 1 |
| +3 | K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021 | — |
| +4 | K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K072886 | Medrad Stellant CT Injector System with P3TSummary page 1…Cardiac PREDICATE DEVICES: MEDRAD Stellant CT Injector System with P3TFm CardiacFlow (K072886) Stellant Injector System INTENDED USE: P3Tr m Cardiac is intended for use with CT Angiography. P3'F m Cardiac comp… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX… | 2018 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2016 | Class II | Z-2768-2016 | Under Investigation by firm | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. |
| Sep 20, 2013 | Class II | Z-1686-2015 | Software design | The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K173773 (Bayer Medical Care, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K072886.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
INTENDED USE: P3T Cardiac is intended for use with CT Angiography. P3T Cardiac computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.
INDICATIONS FOR USE: P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082905: Medrad Stellant CT Injector System with P3T Cardiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082905
Report an extraction error
Are you the manufacturer?
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