510(k) · Cleared
ClearedMerit Coronary Control Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Jun 15, 2017 as substantially equivalent to K113198 (Navilyst Medical, Inc., 2011) and 1 other predicate after a 224-day review. Its family tree reaches back 3 generations to 1998. 2 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 15, 2017
- Review
- 224 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980580 (1998). 5 ancestors in all, the oldest K873955 (1988). 1 later device descends from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 2 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 1 generation backK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- This deviceK163084 Merit Coronary Control SyringeMerit Medical Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK242143 Angiography InjectorShandong Int Medical Instruments Co., Ltd. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K242143Angiography InjectorShandong Int Medical Instruments Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −2 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −1 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| 0 (this device) | K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K113198 | Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLSummary page 4…tory Class: 2 Predicate Product Code: DXT Device 21 CFR §: 870.1650 Premarket Notification: K113198 Manufacturer: Navilyst Medical, Inc. Trade Name: Welmed Hypo… | 2011 |
| * | K070936 | Welmed Hypodermic SyringeSummary page 4…lass: 2 Predicate Product Code: FMF Device 21 CFR §: 880.5860 Premarket Notification: K070936 Manufacturer: Welmed, Inc. The Merit Coronary Control Syringe contains a… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242143 | Angiography Injector | 2024 | 0 |
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 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K873955Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · 2 generations back · ◆ in the 1988 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K242143 (Shandong Int Medical Instruments Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113198.
How does its category compare?
All DXT devicesDXT 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
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 Merit Coronary Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media. The syringe 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/K163084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163084: Merit Coronary Control Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163084
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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