510(k) Report

510(k) · Cleared

Recalled · 2005

Medrad Stellant CT Injector System with Imaging System Interface Module

K033881510(k) SpecialCleared Mar 2, 200478-day reviewClass II21 CFR 870.1650Recalls 1

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

Medrad, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Mar 2, 2004 as substantially equivalent to K023183 (Medrad, Inc., 2003) after a 78-day review. Its family tree reaches back 3 generations to 1995. 34 later devices descend from it. It has been recalled once.

Decided
Mar 2, 2004
Review
78 days
Class
Class II
Product code
DXT
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K934086 (1995). 34 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2005: 2 descendants cleared2006: 2 descendants cleared2014: 2 descendants cleared2008: 3 descendants cleared2017: 3 descendants cleared2024: 2 descendants cleared2018: 5 descendants cleared2009: 2 descendants cleared2016: 3 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2026: 2 descendants 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 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 7 descendants4 generations forward: 8 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants K023183 · 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+5
  1. Root · 3 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 2 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. 1 generation backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
  4. This deviceK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004
  5. Descendant · cites it directly · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  6. Descendant · 2 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
  7. Descendant · 3 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
  8. Descendant · cites it directly · 7 of its ownK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
  9. Descendant · cites it directly · 6 of its ownK063090 Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc. · 2007

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2005: 22006: 22007: 22008: 32009: 22014: 22016: 32017: 32018: 52019: 12020: 22021: 22024: 22025: 12026: 2
2005high 5 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 34 · See all
  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · cites it directly18descendants
  • K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 2 generations on15descendants
  • K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 3 generations on8descendants
  • K072886Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007 · cites it directly7descendants
  • K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc. · 2007 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−2K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
−1K023183Medrad Stellant CT Injector SystemMedrad, Inc.20036
0 (this device)K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.2004—
+1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
+2K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008—
+3K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016—
+1K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.2007—
+1K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200620
200720
200830
200920
201420
201630
201730
201850
201910
202020
202120
202420
202510
202620
FIG. 1 — Lineage of K033881, 1995–2026Source: 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 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. #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 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
*K023183Medrad Stellant CT Injector System
Summary page 1
…tellant CT Injector System wilh Imaging System Interface Module PREDICATE DEVICE: Medrad Stellant CT Injector System (IK023183) INTENDED USE: The Medrad Stellant CT Injector System is intended for the…
Medrad, Inc.20036

Also cleared against K023183: 2 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518
K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.20077
K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, Inc.20076
K052633Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd.20053
K061976Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C20061

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2005Not classifiedZ-0154-06Otherthe heat maintainer, an accessory, may overheat and deform the disposable syringe

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K051799 (Coeur, Inc., 2005) has gone furthest, with 18 descendants of its own.
  • 2 other devices also cite its predicate K023183.

How does its category compare?

All DXT devices

DXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXT

1in 2025

2007: 32008: 22009: 62010: 12011: 42013: 22014: 62015: 72016: 82017: 72018: 92019: 42020: 32021: 12023: 12024: 42025: 12026 (partial year): 7
2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXT

138in 2024

2007: 182 days median2009: 137 days median2011: 69 days median2014: 144 days median2015: 153 days median2016: 172 days median2017: 183 days median2018: 93 days median2019: 96 days median2020: 154 days median2024: 138 days median2026 (partial year): 264 days median
2007high 264 (2026) · low 69 (2011)2026

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

Recalls per year · DXT

10in 2024

2007: 42008: 32009: 72010: 32011: 32012: 72015: 12018: 22020: 12021: 12023: 22024: 102026 (partial year): 6
2007high 10 (2024) · low 0 (2013)2026

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

Adverse event reports per year · DXT

97in 2025

2007: 1072008: 1682009: 1882010: 1242011: 1332012: 1352013: 1412014: 972015: 1352016: 1522017: 1282018: 1292019: 1212020: 932021: 1322022: 1112023: 1172024: 1182025: 97
2007high 188 (2009) · low 93 (2020)2025

MAUDE reports naming product code DXT, 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
200731824107
20082—3168
200961377188
20101—3124
20114693133
20120—7135
20132—0141
20146144097
201571531135
201681720152
201771830128
20189932129
20194960121
20203154193
20211—1132
20220—0111
20231—2117
2024413810118
20251—097
202672646—

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 ISI module option is intended for the specific purpose of allowing an injector to interface with a CT scanner.

Indications for use as stated in the FDA summary.

Also cleared against K023183

2 other devices cite the same predicate.

  • K052633Dual Shot - Contrast Delivery SystemNemoto Kyorindo Co., Ltd. · 2005
  • K031483Medrad Manual Syringe LoaderMedrad, Inc. · 2003

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 DXT

The DXT category page

  • K262043MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12)…Bayer Medical Care, Inc. · 2026
  • K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for…Fortis Biosolutions Company Limited · 2026
  • K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro…Acist Medical Systems, Inc. · 2026
  • K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single…Acist Medical Systems, Inc. · 2026
  • K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd. · 2026

https://510kreport.com/device/K033881 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033881: Medrad Stellant CT Injector System with Imaging System Interface Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033881

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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