510(k) · Cleared
Recalled · 2003Monarch (in 2125)/Intellisystem (in 1125)
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 Nov 25, 1997 after a 90-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 25, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 3
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK973230 Monarch (in 2125)/Intellisystem (in 1125)Merit Medical Systems, Inc. · 1997
- Descendant · cites it directly · 8 of its ownK011811 Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 4 of its ownK083523 Monarch Compak Inflation Syringe and Universal Fluid Dispensing…Merit Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 3 of its ownK122321 Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · Recalled
- Descendant · 4 generations on · 2 of its ownK130566 BasixtouchMerit Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK160107 DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2016 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K011811Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2001 · cites it directly8descendants
- K083523Monarch Compak Inflation Syringe and Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2009 · 2 generations on4descendants
- K122321Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · 3 generations on3descendants
- K130566BasixtouchMerit Medical Systems, Inc. · 2013 · 4 generations on2descendants
- K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973230 | Monarch (in 2125)/Intellisystem (in 1125) | Merit Medical Systems, Inc. | 1997 | — |
| +1 | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2001 | 10 |
| +2 | K083523 | Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2009 | 1 |
| +3 | K122321 | Basixconpak Analog Inflation Syringe | Merit Medical Ireland, Ltd. | 2012 | 1 |
| +4 | K130566 | Basixtouch | Merit Medical Systems, Inc. | 2013 | — |
| +2 | K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Merit Medical Medallion Syringe Named without a submission number |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2003 | Not classified | Z-0620-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
| Feb 13, 2003 | Not classified | Z-0621-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
| Feb 13, 2003 | Not classified | Z-0622-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011811 (Merit Medical Systems, Inc., 2001) has gone furthest, with 8 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 | — |
What is it indicated for?
The Universal Fluid Dispensing Syringe is Merit Medical’s Monarch Syringe and Intellisystem Syringe intended to be used by healthcare professionals to inject fluids into the body and monitor the pressure of that fluid.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973230: Monarch (in 2125)/Intellisystem (in 1125).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973230
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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