510(k) · Cleared
ClearedDisposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Weigao Medical Polymer Co., Ltd. · DXT Injector And Syringe, Angiographic
Cleared on Mar 23, 2009 as substantially equivalent to K072696 (Shenzhen Ant Hi-Tech Industrial Co., Ltd., 2008) after a 210-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 23, 2009
- Review
- 210 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K934086 (1995). 19 ancestors in all, the oldest K822536 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK934086 Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 1995
- 5 generations backK993728 Medrad Envision CT Injector SystemMedrad, Inc. · 1999
- 4 generations backK023183 Medrad Stellant CT Injector SystemMedrad, Inc. · 2003 · Recalled
- 3 generations backK033881 Medrad Stellant CT Injector System with Imaging System Interface…Medrad, Inc. · 2004 · Recalled
- 2 generations backK051799 Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc. · 2005
- 1 generation backK072696 Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd. · 2008
- This deviceK082439 Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA…Shandong Weigao Medical Polymer Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK162088 Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC · 2017
- Descendant · cites it directly · 0 of its ownK152906 Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934086 | Medrad Envision CT Injector and Qwik Fit Syringe | Medrad, Inc. | 1995 | — |
| −5 | K993728 | Medrad Envision CT Injector System | Medrad, Inc. | 1999 | — |
| −4 | K023183 | Medrad Stellant CT Injector System | Medrad, Inc. | 2003 | 6 |
| −3 | K033881 | Medrad Stellant CT Injector System with Imaging System Interface Module | Medrad, Inc. | 2004 | 1 |
| −2 | K051799 | Disposable CT/MR Syringes for Nemoto Injectors | Coeur, Inc. | 2005 | — |
| −1 | K072696 | Ant Angiographic Syringes, Model (S)… | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2008 | — |
| 0 (this device) | K082439 | Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA… | Shandong Weigao Medical Polymer Co., Ltd. | 2009 | — |
| +1 | K162088 | Ecomed Disposable Angiographic Syringes | Ecomed Solutions, LLC | 2017 | — |
| +1 | K152906 | Disposable High Pressure Injector Syringe | Wuxi Yushou Medical Appliances Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
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 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072696 | Ant Angiographic Syringes, Model (S)…Summary page 1…e, angiographic Product Code: DXT Regulation Number: 870.1650 Device Class: II 5. Predicate Device Identification: ANT Angiographic Syringes K-number: K072696 6. Intended Use: Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe i… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K162088 (Ecomed Solutions, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K072696.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082439: Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082439
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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