510(k) · Cleared
Recalled · Class II · 2024Monarch Inflation Syringe; Universal Fluid Dispensing 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 Aug 22, 2001 as substantially equivalent to K943597 (Merit Medical Systems, Inc., 1995) and 1 other predicate after a 72-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it. It has been recalled 10 times.
- Decided
- Aug 22, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943597 (1995). 2 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK943597 Monarch AP (TM)Merit Medical Systems, Inc. · 1995
- This deviceK011811 Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK083523 Monarch Compak Inflation Syringe and Universal Fluid Dispensing…Merit Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK122321 Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK130566 BasixtouchMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK160107 DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK260035 Digital Indeflator INFLANTEUAB Telemedicina · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K083523Monarch Compak Inflation Syringe and Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2009 · cites it directly4descendants
- K122321Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · 2 generations on3descendants
- K130566BasixtouchMerit Medical Systems, Inc. · 2013 · 3 generations on2descendants
- K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2016 · cites it directly1descendant
- K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943597 | Monarch AP (TM) | Merit Medical Systems, Inc. | 1995 | — |
| 0 (this device) | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2001 | — |
| +1 | K083523 | Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2009 | 1 |
| +2 | K122321 | Basixconpak Analog Inflation Syringe | Merit Medical Ireland, Ltd. | 2012 | 1 |
| +3 | K130566 | Basixtouch | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2016 | 1 |
| +2 | K260035 | Digital Indeflator INFLANTE | UAB Telemedicina | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K943597 | Monarch AP (TM)Summary page 1…uly 24, 2001 30 ATM Monarch Syringe Balloon Inflation Syringe Monarch™ Inflation Syringe Universal Fluid Dispensing Syringe Cardiovascular Monarch™ Inflation Syringe (K943597) Universal Fluid Dispensing Syringe (K973230) Attachment 3 510(k) Summary SAFETY AND EFFECTIVENESS SUMMARY Dev… | 1995 |
| * | K973230 | Monarch (in 2125)/Intellisystem (in 1125)Summary page 1…nflation Syringe Monarch™ Inflation Syringe Universal Fluid Dispensing Syringe Cardiovascular Monarch™ Inflation Syringe (K943597) Universal Fluid Dispensing Syringe (K973230) Attachment 3 510(k) Summary SAFETY AND EFFECTIVENESS SUMMARY Device Description: The 30 ATM Monarch™ is a 20… | 1997 |
What descends from it? (8)
3 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 |
|---|---|---|---|---|
| Aug 30, 2024 | Class II | Z-0059-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 30, 2024 | Class II | Z-0060-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 30, 2024 | Class II | Z-0061-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 30, 2024 | Class II | Z-0057-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 30, 2024 | Class II | Z-0058-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 30, 2024 | Class II | Z-0062-2025 | Nonconforming Material/Component | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. |
| Aug 19, 2024 | Class II | Z-0069-2025 | Packaging process control | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| Mar 23, 2011 | Not classified | Z-3175-2011 | Employee error | Device was shipped past the labeled expiration date. |
| Oct 13, 2003 | Not classified | Z-0146-04 | Other | Devices for which sterility may be compromised as evidenced by a loss of package integrity. |
| Oct 1, 2003 | Not classified | Z-0137-04 | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K083523 (Merit Medical Systems, Inc., 2009) has gone furthest, with 4 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 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to 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/K011811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011811: Monarch Inflation Syringe; Universal Fluid Dispensing Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011811
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026