510(k) Report

510(k) · Cleared

Cleared

CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip

K170431510(k) TraditionalCleared Aug 18, 2017186-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 Aug 18, 2017 as substantially equivalent to K051799 (Coeur, Inc., 2005) and 4 other predicates after a 186-day review. Its family tree reaches back 5 generations to 1995.

Decided
Aug 18, 2017
Review
186 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K934086 (1995). 24 ancestors in all, the oldest K822536 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2007: 2 other ancestors1996: 1 other ancestor2003: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestorK934086 · 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 · recalledK051799 · Disposable CT/MR Syringes for Nemoto Injectors · Coeur, Inc. · 20051980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors3 generations back: 4 other ancestors K051799 · Disposable CT/MR Syringes for Nemoto Injectors · Coeur, Inc. · 2005K033881 · 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 · 5 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
  2. 4 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
  3. 3 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
  4. 2 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
  5. 1 generation backK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  6. This deviceK170431 CT Syringe for Stellant Injectors (with & without Spikes, Prime…Coeur, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc.1995—
−4K993728Medrad Envision CT Injector SystemMedrad, Inc.1999—
−3K023183Medrad Stellant CT Injector SystemMedrad, Inc.20036
−2K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc.20041
−1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
0 (this device)K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill…Coeur, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198510
198710
198810
199210
199310
199510
199610
199720
199810
199910
200010
200110
200320
200720
201610
FIG. 1 — Lineage of K170431, 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? (5)

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
*K051799Disposable CT/MR Syringes for Nemoto Injectors
Summary page 4
…Angiographic 3. Legally Marketed Devices to which Substantial Equivalence is claimed: Coeur: • Coeur Syringes for Nemoto Injectors (K051799) (Primary Predicate Device) • Coeur Front Load Injector Turret & 200mL Front Load Syringe (K960965) (Secon…
Coeur, Inc.2005—
*K960965Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211
Summary page 4
…Coeur: • Coeur Syringes for Nemoto Injectors (K051799) (Primary Predicate Device) • Coeur Front Load Injector Turret & 200mL Front Load Syringe (K960965) (Secondary Predicate Device) • Coeur Adapters for CT, Angiographic, and/or MRI Power Injectors (K070798)…
Coeur Laboratories, Inc.1996—
*K070798Adapters for CT, Angiographic, and/or Mri Power Injectors
Summary page 4
…jector Turret & 200mL Front Load Syringe (K960965) (Secondary Predicate Device) • Coeur Adapters for CT, Angiographic, and/or MRI Power Injectors (K070798) (Secondary Predicate Device) • Coeur MR Syringe Dual Pack for Solaris Injectors (K161471) (Seconda…
Coeur, Inc.2007—
*K161471MR Syringe Dual Pack for Solaris Injectors
Summary page 4
…for CT, Angiographic, and/or MRI Power Injectors (K070798) (Secondary Predicate Device) • Coeur MR Syringe Dual Pack for Solaris Injectors (K161471) (Secondary Predicate Device) Medrad: • Syringe included in Medrad® Stellant® CT Injector System w…
Coeur, Inc.2016—
*K063090Medrad Stellant CT Injector System with XDS Accessory
Summary page 4
…(K161471) (Secondary Predicate Device) Medrad: • Syringe included in Medrad® Stellant® CT Injector System with XDS Accessory (K063090) (Secondary Predicate Device) 4. Device Description: The 200mL Syringe for Stellant Injectors are syringes / kits inten…
Medrad, Inc.2007—

Also cleared against K051799: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
  • 5 of the 24 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K051799.

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. 2017, 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 with the Medrad® Stellant® CT Injection System equipped with the appropriate Coeur Fascia and Ram Tip for the injection of contrast media or saline to the vascular system for diagnostic purposes.

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 K051799

3 other devices cite the same predicate.

  • K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd. · 2024
  • K140469MR Syringe Dual PackCoeur, Inc. · 2014
  • K072696Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008

More from Coeur, Inc.

14 FDA decisions under this applicant name. See the company

  • 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
  • K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, 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/K170431 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170431: CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170431

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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