510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT

K173773510(k) TraditionalCleared Aug 17, 2018248-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

Bayer Medical Care, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Aug 17, 2018 as substantially equivalent to K082905 (Medrad, Inc., 2009) and 1 other predicate after a 248-day review. Its family tree reaches back 6 generations to 1995. 4 later devices descend from it. It has been recalled once.

Decided
Aug 17, 2018
Review
248 days
Class
Class II
Product code
DXT
Recalls
1
Predicates
2

Its longest line of descent runs back 6 generations to K934086 (1995). 10 ancestors in all, the oldest K912944 (1992). 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor1992: 1 other ancestor2018: 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 · recalledK072886 · Medrad Stellant CT Injector System with P3T · Medrad, Inc. · 2007K082905 · Medrad Stellant CT Injector System with P3T Cardiac · Medrad, Inc. · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K082905 · Medrad Stellant CT Injector System with P3T Cardiac · Medrad, Inc. · 2009 · recalledK072886 · Medrad Stellant CT Injector System with P3T · Medrad, Inc. · 2007K033881 · 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. · 1995−50
  1. Root · 6 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 5 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. 4 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
  4. 3 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
  5. 2 generations backK072886 Medrad Stellant CT Injector System with P3TMedrad, Inc. · 2007
  6. 1 generation backK082905 Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc. · 2009 · Recalled
  7. This deviceK173773 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018
  8. Descendant · cites it directly · 3 of its ownK182273 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation…Bayer Medical Care, Inc. · 2018 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK210541 ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021
  10. Descendant · 3 generations on · 0 of its ownK251295 ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025
  11. Descendant · 2 generations on · 0 of its ownK192370 MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc. · 2018 · cites it directly3descendants
  • K210541ulrichINJECT CT motionUlrich GmbH & Co. KG · 2021 · 2 generations on1descendant
  • K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG · 2025 · 3 generations on0descendants
  • K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−5K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
−4K023183Medrad Stellant CT Injector SystemMedrad, Inc.20036
−3K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.20041
−2K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.2007—
−1K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.20092
0 (this device)K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.2018—
+1K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD…Bayer Medical Care, Inc.20181
+2K210541ulrichINJECT CT motionUlrich GmbH & Co. KG2021—
+3K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025—
+2K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
200310
200410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202110
202510
FIG. 1 — Lineage of K173773, 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
*K082905Medrad Stellant CT Injector System with P3T Cardiac
Summary page 5
…devices: Injector System – MEDRAD Stellant CT Injector System with P3T Cardiac, K082905 Bayer Medical Care Inc. 510(k) Summary Page 1 of 16 Traditional 5…
Medrad, Inc.20092
*K063090Medrad Stellant CT Injector System with XDS Accessory
Summary page 6
…ndary Predicate Device: Syringe Kit – MEDRAD Stellant CT Injector System with Extravasation Detection System Accessory, K063090 Device Description: MEDRAD Stellant FLEX CT Injection System with Certegra…
Medrad, Inc.2007—

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.20183

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 14, 2018Class IIZ-0745-2019Device DesignIf the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
  • 6 of the 10 ancestors have a recall of any class.
  • Of its descendants, K182273 (Bayer Medical Care, Inc., 2018) has gone furthest, with 3 descendants of its own.

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. 2018, 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?

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications. MEDRAD® Stellant FLEX Syringe Kits The MEDRAD® Stellant FLEX CT Injection System with…

Read the full statement (321 words)

MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation

The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant FLEX Syringe Kits

The MEDRAD® Stellant FLEX CT Injection System with Certegra Workstation, including Stellant FLEX CT Syringe Kits and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant CT Injection System with Certegra Workstation

The MEDRAD® Stellant CT Injection System with Certegra Workstation is indicated for the specific purpose of injecting intravenous contrast media or saline into humans for diagnostic studies in computed tomography (CT) applications.

MEDRAD® Stellant Syringe Kits

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

MEDRAD® Stellant Connector Tubing

The contents of this package are intended to be used in the delivery of contrast media or saline. They are indicated for single-use on one patient only with MEDRAD® Stellant Injectors.

P3T Cardiac

P3T Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.

P3T PA

P3T PA is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, thoracic, and abdominal aorta.

P3T Abdomen

P3T Abdomen is indicated for use with CT imaging of abdominal organs (i.e., liver, pancreas, kidneys).

ISI

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

Connect.CT

The Connect.CT application is indicated for the specific purpose of allowing the injector to interface with a CT scanner.

Indications for use as stated in the FDA summary.

More from Bayer Medical Care, Inc.

11 FDA decisions under this applicant name. See the company

  • K262043MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12)…Bayer Medical Care, Inc. · 2026
  • K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
  • K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc. · 2026
  • K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc. · 2025
  • K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020

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/K173773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173773: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173773

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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