510(k) Report

510(k) · Cleared

Cleared

Medrad Envision CT Injector System

K993728510(k) SpecialCleared Nov 26, 199922-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 Nov 26, 1999 as substantially equivalent to K934086 (Medrad, Inc., 1995) after a 22-day review. Its family tree reaches back 1 generation to 1995. 39 later devices descend from it.

Decided
Nov 26, 1999
Review
22 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K934086 (1995). 39 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2007: 3 descendants cleared2003: 2 descendants cleared2005: 2 descendants cleared2004: 1 descendant cleared2017: 3 descendants cleared2006: 2 descendants cleared2008: 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. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 8 descendants5 generations forward: 7 descendants6 generations forward: 7 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants K934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 19950+5
  1. Root · 1 generation backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. This deviceK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. Descendant · cites it directly · 36 of its ownK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 34 of its ownK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
  5. Descendant · 3 generations on · 18 of its ownK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  6. Descendant · 4 generations on · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
  7. Descendant · 5 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 22006: 22007: 32008: 32009: 22014: 32016: 32017: 32018: 52019: 12020: 22021: 22024: 22025: 12026: 2
2003high 5 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 39 · See all
  • K023183Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · cites it directly36descendants
  • K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc. · 2004 · 2 generations on34descendants
  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005 · 3 generations on18descendants
  • K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · 4 generations on15descendants
  • K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
0 (this device)K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
+1K023183Medrad Stellant CT Injector SystemMedrad, Inc.20036
+2K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.20041
+3K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
+4K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008—
+5K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200520
200620
200730
200830
200920
201430
201630
201730
201850
201910
202020
202120
202420
202510
202620
FIG. 1 — Lineage of K993728, 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
*K934086Medrad Envision CT Injector and Qwik Fit Syringe
Summary page 1
…Syringe, Angiographic Common/UsualName: Powered Injector with Syringe Proprietary Name: EnVision CT Injection System . Predicate Device: EnVision CT Injection System {(K934086) Device Descripticn: . Technical Description: The Medrad EnVision CT Injection System is a modified version of the EnVision CT…
Medrad, Inc.1995—

Also cleared against K934086: 3 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K023183Medrad Stellant CT Injector SystemMedrad, Inc.200336
K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc.20072
K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.20140

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?

  • Its one ancestor has no recall.
  • Of its descendants, K023183 (Medrad, Inc., 2003) has gone furthest, with 36 descendants of its own.
  • 3 other devices also cite its predicate K934086.

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 EnVision CT Injection System s a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast medium into the human vascular system for diagnostic studies in computed tomography.

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 K934086

3 other devices cite the same predicate.

  • K023183Medrad Stellant CT Injector SystemMedrad, Inc. · 20036 recalls
  • K983314Premica CT Contrast Media Delivery SystemNycomed Amersham Imaging · 1999
  • K982814Medrad Vistron CT Injector SystemMedrad, Inc. · 1998

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/K993728 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993728: Medrad Envision CT Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993728

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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