510(k) Report

510(k) · Cleared

Cleared

Medrad Stellant CT Injector System with P3T

K072886510(k) TraditionalCleared Dec 21, 200773-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. · DXT Injector And Syringe, Angiographic

Cleared on Dec 21, 2007 as substantially equivalent to K033881 (Medrad, Inc., 2004) and 1 other predicate after a 73-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.

Decided
Dec 21, 2007
Review
73 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K934086 (1995). 7 ancestors in all, the oldest K912944 (1992). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1992: 1 other ancestor2008: 1 descendant cleared2009: 1 descendant cleared2018: 2 descendants 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 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+5
  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 deviceK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
  6. Descendant · cites it directly · 5 of its ownK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
  7. Descendant · 2 generations on · 4 of its ownK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  8. Descendant · 3 generations on · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  9. Descendant · 4 generations on · 1 of its ownK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
  10. Descendant · 5 generations on · 0 of its ownK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12018: 22019: 12021: 12025: 1
2008high 2 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · cites it directly5descendants
  • K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 2 generations on4descendants
  • K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · 3 generations on3descendants
  • K210541ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021 · 4 generations on1descendant
  • K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025 · 5 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)K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.2007—
+1K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.20092
+2K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+3K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+4K210541ulrichINJECT CT motionUlrich GmbH & Co. KG2021—
+5K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201820
201910
202110
202510
FIG. 1 — Lineage of K072886, 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 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? (2)

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
…CardiacFlow PREDICATE DEVICES: MEDRAD Stellant CT Injector System with Imaging System Interface Module (K033881) OptiVantage DH Injection System (K042744) Mallinckrodt, Inc., L…
Medrad, Inc.20041
*K042744Optiv Antage DH Power Injection System
Summary page 1
…llant CT Injector System with Imaging System Interface Module (K033881) OptiVantage DH Injection System (K042744) Mallinckrodt, Inc., Liebel-Flarsheim Business INTENDED USE: The MEDRAD Stellant CT Injector Sys…
Mallinckrodt Inc., Liebel-Flarsheim Business20041

Also cleared against K033881: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.20095
K082458P3T AbdomenMedrad, Inc.20080

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 3.8 years on median.
  • 5 of the 7 ancestors have a recall of any class.
  • Of its descendants, K082905 (Medrad, Inc., 2009) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K033881.

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. 2007, this device’s year, is highlighted.

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 Stellant P3T software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.

The Stellant P3T software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K033881

4 other devices cite the same predicate.

  • K063090Medrad Stellant CT Injector System with XDS AccessoryMedrad, 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 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/K072886 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072886: Medrad Stellant CT Injector System with P3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072886

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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