510(k) Report

510(k) · Cleared

Cleared

Disposable CT/MR Syringes for Nemoto Injectors

K051799510(k) TraditionalCleared Nov 2, 2005120-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 Nov 2, 2005 as substantially equivalent to K965214 (Coeur Laboratories, Inc., 1997) and 9 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1995. 18 later devices descend from it.

Decided
Nov 2, 2005
Review
120 days
Class
Class II
Product code
DXT
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K934086 (1995). 17 ancestors in all, the oldest K822536 (1982). 18 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1996: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestor2014: 1 descendant cleared2008: 1 descendant cleared2017: 3 descendants cleared2024: 2 descendants cleared2016: 3 descendants cleared2018: 2 descendants cleared2009: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2026: 2 descendants 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants 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 deviceK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
  6. Descendant · cites it directly · 15 of its ownK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
  7. Descendant · 2 generations on · 8 of its ownK151960 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016
  8. Descendant · 3 generations on · 4 of its ownK192657 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020
  9. Descendant · 4 generations on · 2 of its ownK211564 Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021
  10. Descendant · 2 generations on · 2 of its ownK082439 Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA…Shandong Weigao Medical Polymer Co., Ltd. · 2009

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12014: 12016: 32017: 32018: 22020: 22021: 12024: 22026: 2
2008high 3 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 18 · See all
  • K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008 · cites it directly15descendants
  • K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd. · 2016 · 2 generations on8descendants
  • K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2020 · 3 generations on4descendants
  • K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd. · 2021 · 4 generations on2descendants
  • K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd. · 2009 · 2 generations on2descendants
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)K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.2005—
+1K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.2008—
+2K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.2016—
+3K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2020—
+4K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.2021—
+2K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA…Shandong Weigao Medical Polymer Co., Ltd.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198510
198710
198810
199210
199310
199510
199610
199720
199810
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201410
201630
201730
201820
202020
202110
202420
202620
FIG. 1 — Lineage of K051799, 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? (10)

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
…ame: Angiographic Injector & Syringe 3. Legally Marketed Devices to which Substantial Equivalence is claimed: Coeurlock DisposableAngiographic Syringe (K965214) - Coeur FrontLoad Injector Turret and 200mL FrontLoadSyringe (K960965) - Coeur Coeur 13OmL Syringe (K971712)- Coeur…
Coeur Laboratories, Inc.1997—
*K960965Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211
Summary page 1
…to which Substantial Equivalence is claimed: Coeurlock DisposableAngiographic Syringe (K965214) - Coeur FrontLoad Injector Turret and 200mL FrontLoadSyringe (K960965) - Coeur Coeur 13OmL Syringe (K971712)- Coeur Syringe for Nemoto 3S Injector, Unimachs Corp., Catalog# 3S Syringe (K9…
Coeur Laboratories, Inc.1996—
*K971712Coeur 130 ML Angiographic Syringe
Summary page 1
…Coeurlock DisposableAngiographic Syringe (K965214) - Coeur FrontLoad Injector Turret and 200mL FrontLoadSyringe (K960965) - Coeur Coeur 13OmL Syringe (K971712)- Coeur Syringe for Nemoto 3S Injector, Unimachs Corp., Catalog# 3S Syringe (K983826) - Approved for Legal Market…
Coeur Laboratories, Inc.1997—
*K9838263S Injector-CT Contrast Delivery System
Summary page 1
…Turret and 200mL FrontLoadSyringe (K960965) - Coeur Coeur 13OmL Syringe (K971712)- Coeur Syringe for Nemoto 3S Injector, Unimachs Corp., Catalog# 3S Syringe (K983826) - Approved for Legal Marketingfor Unimachs Corporation Medrad Stellant CT Injector System with Imaging System In…
Unimachs Corp.2000—
*K033881Medrad Stellant CT Injector System with Imaging System Interface Module
Summary page 1
…log# 3S Syringe (K983826) - Approved for Legal Marketingfor Unimachs Corporation Medrad Stellant CT Injector System with Imaging System Interface Module (K033881) - Medrad, Inc. Medrad MicroprocessorCT Injection System (K880493) - Medrad, Inc. CT 9000 DigitalInjection…
Medrad, Inc.20041
*K880493Medrad Microprocessor CT Injection System
Summary page 1
…poration Medrad Stellant CT Injector System with Imaging System Interface Module (K033881) - Medrad, Inc. Medrad MicroprocessorCT Injection System (K880493) - Medrad, Inc. CT 9000 DigitalInjection System (K912944) - Mallinckrodt Inc., Liebel-Flarsheim Business Op…
Medrad, Inc.1988—
*K912944CT 8000 Digital Injection System
Summary page 1
…System Interface Module (K033881) - Medrad, Inc. Medrad MicroprocessorCT Injection System (K880493) - Medrad, Inc. CT 9000 DigitalInjection System (K912944) - Mallinckrodt Inc., Liebel-Flarsheim Business OptiStarMR Injection System (K984088) - Mallinckrodt Inc., Liebel…
Mallinckrodt Group, Inc.19921
*K984088Optistar MR Injector System
Summary page 1
…stem (K880493) - Medrad, Inc. CT 9000 DigitalInjection System (K912944) - Mallinckrodt Inc., Liebel-Flarsheim Business OptiStarMR Injection System (K984088) - Mallinckrodt Inc., Liebel-FlarsheimBusiness E-Z-EM Percupump L4 (K86422 7) - E-Z-EM, Inc. Oz Power Syringe (K97333…
Mallinckrodt Inc., Liebel-Flarsheim Business19995
*K864227Percupump (TM)
Summary page 1
…llinckrodt Inc., Liebel-Flarsheim Business OptiStarMR Injection System (K984088) - Mallinckrodt Inc., Liebel-FlarsheimBusiness E-Z-EM Percupump L4 (K86422 7) - E-Z-EM, Inc. Oz Power Syringe (K973334) - CardiovascularInnovations 4. Device Description: The Disposable CT/MR S…
E-Z-Em, Inc.1987—
*K973334OZ Power Syringe
Summary page 1
…ess OptiStarMR Injection System (K984088) - Mallinckrodt Inc., Liebel-FlarsheimBusiness E-Z-EM Percupump L4 (K86422 7) - E-Z-EM, Inc. Oz Power Syringe (K973334) - CardiovascularInnovations 4. Device Description: The Disposable CT/MR Syringesfor Nemoto Injectors are plastic, single-…
Cardiovascular Innovations19982

Also cleared against K965214: 1 other device →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815
K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240
K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170
K140469MR Syringe Dual PackCoeur, 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 10 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
  • 5 of the 17 ancestors have a recall of any class.
  • Of its descendants, K072696 (Shenzhen Ant Hi-Tech Industrial Co., Ltd., 2008) has gone furthest, with 15 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.

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?

Syringe for injection of contrast media or saline for CT and MR imaging, for use on Nemoto injectors.

Indications for use as stated in the FDA summary.

Also cleared against K965214

1 other device cites the same predicate.

  • K070798Adapters for CT, Angiographic, and/or Mri Power InjectorsCoeur, Inc. · 2007

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/K051799 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051799: Disposable CT/MR Syringes for Nemoto Injectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051799

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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