510(k) Report

510(k) · Cleared

Cleared

Medrad Stellant CT Injector System with XDS Accessory

K063090510(k) TraditionalCleared Mar 27, 2007168-day reviewClass II21 CFR 870.1650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medrad, Inc. · IZQ Injector, Contrast Medium, Automatic

Cleared on Mar 27, 2007 as substantially equivalent to K033881 (Medrad, Inc., 2004) after a 168-day review. Its family tree reaches back 4 generations to 1995. 6 later devices descend from it.

Decided
Mar 27, 2007
Review
168 days
Class
Class II
Product code
IZQ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K934086 (1995). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant clearedK934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 1995K993728 · Medrad Envision CT Injector System · Medrad, Inc. · 1999K023183 · Medrad Stellant CT Injector System · Medrad, Inc. · 2003 · recalledK033881 · Medrad Stellant CT Injector System with Imaging System Interface Module · Medrad, Inc. · 2004 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant K033881 · Medrad Stellant CT Injector System with Imaging System Interface Module · Medrad, Inc. · 2004 · recalledK023183 · Medrad Stellant CT Injector System · Medrad, Inc. · 2003 · recalledK993728 · Medrad Envision CT Injector System · Medrad, Inc. · 1999K934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 19950
  1. Root · 4 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 3 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. 2 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
  4. 1 generation backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
  5. This deviceK063090 Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc. · 2007
  6. Descendant · cites it directly · 4 of its ownK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
  9. Descendant · 4 generations on · 0 of its ownK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
  10. Descendant · 3 generations on · 0 of its ownK192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 22019: 12021: 12025: 1
2017high 2 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−4K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−3K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
−2K023183Medrad Stellant CT Injector SystemMedrad, Inc.20036
−1K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.20041
0 (this device)K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc.2007—
+1K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+2K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+3K210541ulrichINJECT CT motionUlrich GmbH & Co. KG2021—
+4K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025—
+3K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.20191

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
201910
202110
202510
FIG. 1 — Lineage of K063090, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241850 ulricheasyINJECT Max 2M (XD 10140)…score 12.7 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033881Medrad Stellant CT Injector System with Imaging System Interface Module
Summary page 1
…stem with XDS Accessory PREDICATE DEVICE: MEDRAD Stellant CT Injector System with Imaging System Interface Module (K033881) INTENDED USE: The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast med…
Medrad, Inc.20041

Also cleared against K033881: 4 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.20184
K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170

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 12 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
  • 2 of the 4 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.
  • 4 other devices also cite its predicate K033881.

How does its category compare?

All IZQ devices

IZQ Injector, Contrast Medium, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IZQ

3in 2025

2007: 32010: 12016: 22017: 12020: 12021: 12024: 32025: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZQ

119in 2025

2007: 168 days median2024: 131 days median2025: 119 days median
2007high 168 (2007) · low 119 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZQ

2in 2011

2008: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZQ

21in 2025

2007: 142008: 722009: 482010: 422011: 412012: 232013: 232014: 142015: 52016: 72017: 32018: 82019: 92020: 132021: 142022: 242023: 162024: 232025: 21
2007high 72 (2008) · low 3 (2017)2025

MAUDE reports naming product code IZQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073168014
20080—172
20090—048
20101—042
20110—241
20120—023
20130—023
20140—014
20150—05
20162—07
20171—03
20180—08
20190—09
20201—013
20211—014
20220—024
20230—016
20243131023
20253119021
20261—0—

What is it indicated for?

The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.

Indications for use as stated in the FDA summary.

Also cleared against K033881

4 other devices cite the same predicate.

  • K072886Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
  • K061976Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C · 2006
  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  • K052633Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd. · 2005

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

Recent decisions in IZQ

The IZQ category page

  • K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc. · 2026
  • K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG · 2025
  • K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
  • K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo…Imaxeon Pty, Ltd. · 2025
  • K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo…Imaxeon Pty, Ltd. · 2024

https://510kreport.com/device/K063090 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063090: Medrad Stellant CT Injector System with XDS Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063090

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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