510(k) · Cleared
Recalled · Class II · 2024Monarch Compak Inflation Syringe and 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 Feb 4, 2009 as substantially equivalent to K011811 (Merit Medical Systems, Inc., 2001) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943597 (1995). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK943597 Monarch AP (TM)Merit Medical Systems, Inc. · 1995
- 1 generation backK011811 Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2001 · Recalled
- This deviceK083523 Monarch Compak Inflation Syringe and Universal Fluid Dispensing…Merit Medical Systems, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK122321 Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK130566 BasixtouchMerit Medical Systems, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK153672 basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
Most influential descendants
Showing 4 of 4 · See all- K122321Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · cites it directly3descendants
- K130566BasixtouchMerit Medical Systems, Inc. · 2013 · 2 generations on2descendants
- K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016 · 3 generations on0descendants
- K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943597 | Monarch AP (TM) | Merit Medical Systems, Inc. | 1995 | — |
| −1 | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2001 | 10 |
| 0 (this device) | K083523 | Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2009 | — |
| +1 | K122321 | Basixconpak Analog Inflation Syringe | Merit Medical Ireland, Ltd. | 2012 | 1 |
| +2 | K130566 | Basixtouch | Merit Medical Systems, Inc. | 2013 | — |
| +3 | K153672 | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | 2016 | — |
| +3 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | 2001 |
| * | K040138 | Viceroy Inflation DeviceSummary page 1…flation Syringe with Gauge Classification Name: 74 MAV - Angiographic Injector & Syringe Premarket Notification: K040138, clearance date Feb. 13, 2004 Manufacturer: Merit Medical Systems, Inc… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122321 | Basixconpak Analog Inflation Syringe | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 19, 2024 | Class II | Z-0064-2025 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 7.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K122321 (Merit Medical Ireland, Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K011811.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Monarch™ COMPAK Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices, and to measure the pressure within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083523: Monarch Compak Inflation Syringe and 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/K083523
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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