510(k) · Cleared
ClearedAngiography Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Int Medical Instruments Co., Ltd. · DXT Injector And Syringe, Angiographic
Cleared on Dec 23, 2024 as substantially equivalent to K163084 (Merit Medical Systems, Inc., 2017) after a 154-day review. Its family tree reaches back 4 generations to 1998. 2 of the 7 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 23, 2024
- Review
- 154 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980580 (1998). 6 ancestors in all, the oldest K873955 (1988). No later device cites it as a predicate yet. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 3 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 2 generations backK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- 1 generation backK163084 Merit Coronary Control SyringeMerit Medical Systems, Inc. · 2017
- This deviceK242143 Angiography InjectorShandong Int Medical Instruments Co., Ltd. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −3 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −2 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| −1 | K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 1 |
| 2011 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K163084 | Merit Coronary Control SyringeSummary page 5…II Review Panel: Cardiovascular Reason for Submission: New device III. Predicate Devices Primary predicate device 510(k) Number: K163084 Trade name: Merit Coronary Control Syringe Classification: Class II Product Code:… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113198Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLNavilyst Medical, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K873955Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · 3 generations back · ◆ in the 1988 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242143: Angiography Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242143
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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