510(k) · Cleared
Recalled · Class II · 2017Disposable Coronary Control Syringe 12CC
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 Feb 11, 1988 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 15 times.
- Decided
- Feb 11, 1988
- Review
- 56 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 15
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK875196 Disposable Coronary Control Syringe 12CCMerit Medical Systems, Inc. · 1988
- Descendant · cites it directly · 0 of its ownK022735 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with…MicroVention, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875196 | Disposable Coronary Control Syringe 12CC | Merit Medical Systems, Inc. | 1988 | — |
| +1 | K022735 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the… | MicroVention, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K022735 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink… | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2017 | Class II | Z-1889-2017 | Nonconforming Material/Component | Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip. |
| Mar 13, 2014 | Class II | Z-1320-2014 | Release of Material/Component prior to receiving test results | The products are labeled as sterile but were not sterilized. |
| Sep 9, 2010 | Not classified | Z-0063-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 9, 2010 | Not classified | Z-0066-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 9, 2010 | Not classified | Z-0062-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 9, 2010 | Not classified | Z-0061-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 9, 2010 | Not classified | Z-0064-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 9, 2010 | Not classified | Z-0065-2011 | Employee error | Small holes in the packaging may render the product non-sterile. |
| Sep 29, 2009 | Not classified | Z-0520-2010 | Other | Potential sterility breach caused by excessive shipment damage. |
| Jul 9, 2008 | Not classified | Z-2368-2008 | Process control | Control Syringes may be non-sterile due to holes in the packaging. |
| Jul 9, 2008 | Not classified | Z-2367-2008 | Process control | Control Syringes may be non-sterile due to holes in the packaging. |
| Jul 9, 2008 | Not classified | Z-2366-2008 | Process control | Control Syringes may be non-sterile due to holes in the packaging. |
| Sep 14, 2004 | Not classified | Z-0048-05 | Other | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. |
| Sep 14, 2004 | Not classified | Z-0049-05 | Other | Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch. |
| May 16, 2003 | Not classified | Z-0912-03 | Other | Cracks in the syringe barrels could allow for air aspiration into the syringe barrel. |
The 5 latest of 15 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022735 (MicroVention, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K875196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K875196: Disposable Coronary Control Syringe 12CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875196
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026