510(k) · Cleared
ClearedulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
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 Apr 19, 2024 as substantially equivalent to K192872 (Ulrich GmbH & Co. KG, 2020) after a 149-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 19, 2024
- Review
- 149 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K934086 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 5 generations backK983314 Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
- 4 generations backK062265 CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006
- 3 generations backK151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B…Bracco Injeneering · 2016
- 2 generations backK171392 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017
- 1 generation backK192872 ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020
- This deviceK233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
- Descendant · cites it directly · 1 of its ownK241850 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
- Descendant · 2 generations on · 0 of its ownK252281 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2025
Most influential descendants
Showing 2 of 2 · See all- K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2024 · cites it directly1descendant
- K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −5 | K983314 | Premica CT Contrast Media Delivery System | Nycomed Amersham Imaging | 1999 | — |
| −4 | K062265 | CT Expres Iii Contrast Media Delivery System | Swiss Medical Care S.A. | 2006 | — |
| −3 | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III… | Bracco Injeneering | 2016 | — |
| −2 | K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017 | — |
| −1 | K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020 | — |
| 0 (this device) | K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2024 | — |
| +1 | K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2024 | — |
| +2 | K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K192872 | ulrichINJECT CT MotionSummary page 6…ECT CT motion Common Name Contrast Media Management System 510(k) Submitter / Holder Class II 510(k) Number K192872 Regulation Number 21 CFR 870.1650, Angiographic Injector and Syringe Classification Panel Ca… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT… | 2024 | 1 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K241850 (Ulrich GmbH & Co. KG, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192872.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Indications for Use – ulricheasyINJECT Max System (Max 2M (XD 10140) and Max 3 (XD 10150)) ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) 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 magnetic resonance (MR) applications. ulricheasyINJECT Max 2M / 3 (XD 10140 / XD…
Read the full statement (504 words)
Indications for Use – ulricheasyINJECT Max System (Max 2M (XD 10140) and Max 3 (XD 10150))
ulricheasyINJECT Max System Max 2M (XD 10140) and Max 3 (XD 10150) 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 magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of Clariscan (Gadoterate Meglumine) Injection, - GE Healthcare Inc. contrast media as supplied in approved single dose bottles.
Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 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 agent.
The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.
Indications for Use – ulricheasyINJECT Max 3 (XD 10180)
ulricheasyINJECT Max 3 (XD 10180) 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 magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of VUEWAY™ (gadopiclenol), - Bracco Diagnostics Inc, MultiHance (gadobenate dimeglumine) – Bracco Diagnostics, Inc, Clariscan™ (Gadoterate Meglumine) Injection, - GE Healthcare Inc., Dotarem® (gadoterate meglumine) Injection – Guerbet, LLC, and Gadavist™ (gadobutrol) Injection, - Bayer HealthCare Pharmaceuticals Inc., contrast media as supplied in approved single dose vials.
Easy-Click-Cassette – flex Max 3 is used for a maximum time of twenty four (24) hours or a maximum of 96 bottles of contrast media, or whichever comes first. Use time expiration per single dose contrast media container is a maximum of four (4) hours per contrast media container, unless otherwise stated by the contrast media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 3 (XD 10180) 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 agent.
The ulricheasyINJECT Max 3 (XD 10180) is not intended for injection of contrast media (CM) for high-pressure angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233737: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233737
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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