510(k) · Cleared
ClearedulrichINJECT CT Motion (XD 8000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · IZQ Injector, Contrast Medium, Automatic
Cleared on Nov 7, 2025 as substantially equivalent to K210541 (Ulrich GmbH & Co. KG, 2021) after a 196-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Nov 7, 2025
- Review
- 196 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K934086 (1995). 18 ancestors in all, the oldest K912944 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 5 generations between
- 3 generations backK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- 2 generations backK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- 1 generation backK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
- This deviceK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
Show all 9 generations
- Root · 9 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 8 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 7 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 6 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 5 generations backK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
- 4 generations backK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
- 3 generations backK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- 2 generations backK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
- 1 generation backK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
- This deviceK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −8 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −7 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −6 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −5 | K072886 | Medrad Stellant CT Injector System with P3T | Medrad, Inc. | 2007 | — |
| −4 | K082905 | Medrad Stellant CT Injector System with P3T Cardiac | Medrad, Inc. | 2009 | 2 |
| −3 | 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 |
| −1 | K210541 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2021 | — |
| 0 (this device) | K251295 | ulrichINJECT CT Motion (XD 8000) | Ulrich GmbH & Co. KG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 IZQ? 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 IZQ device
- #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 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 |
|---|---|---|---|
| * | K210541 | ulrichINJECT CT motionSummary page 6…ommon Name Contrast Media Management System 510(k) Submitter / Holder ulrich GmbH & Co. KG 510(k) Number K210541 Classification Class II Regulation Number 21 CFR 870.1650, Angiographic Injector a… | 2021 |
| † | K171392 | ulrichINJECT CT motion | 2017 |
| † | K192872 | ulrichINJECT CT Motion | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 18 ancestors have a recall of any class.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IZQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZQ
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZQ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZQ
21in 2025
MAUDE reports naming product code IZQ, 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 | 168 | 0 | 14 |
| 2008 | 0 | — | 1 | 72 |
| 2009 | 0 | — | 0 | 48 |
| 2010 | 1 | — | 0 | 42 |
| 2011 | 0 | — | 2 | 41 |
| 2012 | 0 | — | 0 | 23 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 3 | 131 | 0 | 23 |
| 2025 | 3 | 119 | 0 | 21 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications. ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of the following contrast media: • Iohexol Injection in single-dose (SD) container or…
Read the full statement (308 words)
ulrichINJECT CT motion is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in computed tomography (CT) applications.
ulrichINJECT CT motion is specifically indicated for use in CT procedures for the delivery of the following contrast media:
• Iohexol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
• Iodixanol Injection in SD container
• Iopamidol Injection in IBP
Pump tubing – flex can be used with a maximum of 36 bottles of contrast media or a maximum time of twenty-four (24) hours, whichever comes first.
Use time expiration per SD container is a maximum of four (4) hours from initial puncture, unless otherwise stated by the contrast media labeling.
Use time expiration per IBP is limited to a maximum time stated by the specific contrast media labeling.
Use time expiration per saline container is a maximum of twenty four (24) hours from initial puncture.
Spike for CT disposable is for single-bottle use only and must be discarded with the media container. The maximum time usage for the Spike for CT is twenty four (24) hours, or the maximum use time for the contrast media container indicated for use with ulrichINJECT CT motion, whichever comes first.
The Patient tubing must be discarded after each patient procedure.
SYNCopen is indicated for the specific purpose of allowing an injector to interface with a CT scanner.
RIS/PACS is indicated for the specific purpose of allowing an injector to interface with a Radiological Information System (RIS) and a Picture Archiving and Communications System (PACS).
ulrichINJECT CT motion is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251295: ulrichINJECT CT Motion (XD 8000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251295
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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