510(k) Report

510(k) · Cleared

Cleared

Adapters for CT, Angiographic, and/or Mri Power Injectors

K070798510(k) TraditionalCleared Oct 4, 2007195-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

Coeur, Inc. · DXT Injector And Syringe, Angiographic

Cleared on Oct 4, 2007 as substantially equivalent to K965214 (Coeur Laboratories, Inc., 1997) and 5 other predicates after a 195-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.

Decided
Oct 4, 2007
Review
195 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
6

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

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2014: 1 descendant cleared2017: 1 descendant clearedK934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 1995K993728 · Medrad Envision CT Injector System · Medrad, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants K993728 · Medrad Envision CT Injector System · Medrad, Inc. · 1999K934086 · Medrad Envision CT Injector and Qwik Fit Syringe · Medrad, Inc. · 19950
  1. Root · 2 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 1 generation backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. This deviceK070798 Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc. · 2007
  4. Descendant · cites it directly · 0 of its ownK170431 CT Syringe for Stellant Injectors (with & without Spikes, Prime…Coeur, Inc. · 2017
  5. Descendant · cites it directly · 0 of its ownK133600 Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc. · 2017 · cites it directly0descendants
  • K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−1K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
0 (this device)K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc.2007—
+1K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill…Coeur, Inc.2017—
+1K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199610
199710
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
FIG. 1 — Lineage of K070798, 1995–2017Source: 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? (6)

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
*K965214Coeur Front Load Injector Retrofit Kit (C859-0002)
Summary page 1
…Angiographic 3. Legally Marketed Devices to which Substantial Equivalence is claimed: Coeur Front Load Injector Retrofit Kit (K965214) - Coeur Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur…
Coeur Laboratories, Inc.1997—
*K960965Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211
Summary page 1
…: Coeur Front Load Injector Retrofit Kit (K965214) - Coeur Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc. Medrad Envision CT…
Coeur Laboratories, Inc.1996—
*K912944CT 8000 Digital Injection System
Summary page 1
…- Coeur Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc. Medrad Envision CT Injection System (K993728) - Medrad Coeur Injector…
Mallinckrodt Group, Inc.19921
*K993728Medrad Envision CT Injector System
Summary page 1
…(K960965) - Coeur CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc. Medrad Envision CT Injection System (K993728) - Medrad Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur Medrad MCT, MCT Plus Injector/…
Medrad, Inc.1999—
*K032920The Coeur Injector Adaptor/Pressure Jacket, Model C859-6003
Summary page 1
…ystem (K912944) - Mallinckrodt Group, Inc. Medrad Envision CT Injection System (K993728) - Medrad Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116) - Medrad 4. Device D…
Coeur Medical2003—
*K924116Medrad MCT, MCT Plus Injector/Medrad Front Load
Summary page 1
…) - Medrad Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116) - Medrad 4. Device Description: As defined by 21 CFR 870.1650, an angiographicinjector and syringe is a device…
Medrad, Inc.1993—

Also cleared against K965214: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170
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?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K170431 (Coeur, Inc., 2017) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K965214.

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?

for use in adapting CT and/or Angiographic power injectors for use with Coeur Syringes

Indications for use as stated in the FDA summary.

Also cleared against K965214

1 other device cites the same predicate.

  • K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005

More from Coeur, Inc.

14 FDA decisions under this applicant name. See the company

  • K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack…Coeur, Inc. · 2017
  • K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016
  • K150902330psi Extension Y-Line with Dual Check ValveCoeur, Inc. · 2015
  • K142745125mL CT SyringeCoeur, Inc. · 2015
  • K140469MR Syringe Dual PackCoeur, Inc. · 2014

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/K070798 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070798: Adapters for CT, Angiographic, and/or Mri Power Injectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070798

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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