510(k) · Cleared
ClearedCT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bracco Injeneering · IZQ Injector, Contrast Medium, Automatic
Cleared on Jan 22, 2016 as substantially equivalent to K062265 (Swiss Medical Care S.A., 2006) after a 277-day review. Its family tree reaches back 3 generations to 1995. 9 later devices descend from it.
- Decided
- Jan 22, 2016
- Review
- 277 days
- Class
- Class II
- Product code
- IZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934086 (1995). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 2 generations backK983314 Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
- 1 generation backK062265 CT Expres Iii Contrast Media Delivery SystemSwiss Medical Care S.A. · 2006
- This deviceK151048 CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B…Bracco Injeneering · 2016
- Descendant · cites it directly · 6 of its ownK171392 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017
- Descendant · 2 generations on · 5 of its ownK192872 ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020
- Descendant · 3 generations on · 2 of its ownK233737 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
- Descendant · cites it directly · 1 of its ownK241849 MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD…Imaxeon Pty, Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK241850 ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD…Ulrich GmbH & Co. KG · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171392ulrichINJECT CT motionUlrich GmbH & Co. KG · 2017 · cites it directly6descendants
- K192872ulrichINJECT CT MotionUlrich GmbH & Co. KG · 2020 · 2 generations on5descendants
- K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2024 · 3 generations on2descendants
- K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient…Imaxeon Pty, Ltd. · 2024 · cites it directly1descendant
- K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT…Ulrich GmbH & Co. KG · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −2 | K983314 | Premica CT Contrast Media Delivery System | Nycomed Amersham Imaging | 1999 | — |
| −1 | K062265 | CT Expres Iii Contrast Media Delivery System | Swiss Medical Care S.A. | 2006 | — |
| 0 (this device) | K151048 | CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III… | Bracco Injeneering | 2016 | — |
| +1 | K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | 2017 | — |
| +2 | K192872 | ulrichINJECT CT Motion | Ulrich GmbH & Co. KG | 2020 | — |
| +3 | K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2024 | — |
| +1 | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo… | Imaxeon Pty, Ltd. | 2024 | — |
| +4 | K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150)… | Ulrich GmbH & Co. KG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K062265 | CT Expres Iii Contrast Media Delivery SystemSummary page 4…contrast medium, automatic Regulation Description: Angiographic injector and syringe 3. PREDICATE DEVICE CT Exprés III™ Contrast Media Delivery System, K062265 (Swiss Medical Care, S.A.) 4. DEVICE DESCRIPTION The CT Exprès™ 3D Contrast Media Delivery System (CT Exprès™ 3D) is designe… | 2006 |
What descends from it? (9)
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)
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 21 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171392 (Ulrich GmbH & Co. KG, 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IZQ devicesIZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The CT Expres™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner. The CT Expres™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP)…
Read the full statement (165 words)
The CT Expres™ 3D Contrast Media Delivery System is indicated for controlled automatic administration, on the venous side, of contrast media and saline, to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The CT Expres™ 3D Contrast Media Delivery System is specifically indicated for use in CT procedures for the delivery of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package (IBP), for a maximum of 20 bottles of contrast media or a maximum of ten (10) hours, whichever comes first, per Day Set III HP disposable. The Bottle Spike disposable is for single-bottle use only and must be discarded with the contrast media bottle. The Patient Set disposable must be discarded after each patient procedure.
The CT Expres™ 3D is to be used only by and under quasi-continuous supervision of trained health care professionals in an appropriate licensed health care facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151048: CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151048
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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