510(k) · Cleared
Recalled · 2005Viceroy Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · MAV Syringe, Balloon Inflation
Cleared on Feb 13, 2004 after a 22-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 13, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK040138 Viceroy Inflation DeviceMerit Medical Systems, Inc. · 2004
- 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 · 4 generations on · 0 of its ownK153672 basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016 · 4 generations on0descendants
- K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040138 | Viceroy Inflation Device | Merit Medical Systems, Inc. | 2004 | — |
| +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 | — |
| +4 | K153672 | basixTOUCH40 Inflation Syringe | Merit Medical Systems, Inc. | 2016 | — |
| +4 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 MAV? 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 MAV device
- #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Boston Scientific's LeVeen Inflator Disposable Inflation Syringe Named without a submission number | |
| * | — | Guidant's Indeflator 20/30 Inflation Device Named without a submission number | |
| * | — | Wilson/Cook's Quantum Inflation Device Named without a submission number |
What descends from it? (6)
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 |
|---|---|---|---|---|
| Oct 21, 2005 | Not classified | Z-0290-06 | Other | Inflation device may not hold vacuum during angioplasty procedure. |
| Oct 21, 2005 | Not classified | Z-0291-06 | Other | Inflation device may not hold vacuum during angioplasty procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083523 (Merit Medical Systems, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, 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 | 0 | — | 0 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.
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/K040138 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040138: Viceroy Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040138
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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