510(k) · Cleared
ClearedMastro Plus Balloon in-Deflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Demax Medical Technology Co.,Ltd · MAV Syringe, Balloon Inflation
Cleared on Mar 5, 2015 as substantially equivalent to K130566 (Merit Medical Systems, Inc., 2013) and 2 other predicates after a 325-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Mar 5, 2015
- Review
- 325 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K943597 (1995). 14 ancestors in all, the oldest K884913 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK943597 Monarch AP (TM)Merit Medical Systems, Inc. · 1995
- 4 generations backK011811 Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK083523 Monarch Compak Inflation Syringe and Universal Fluid Dispensing…Merit Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK122321 Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd. · 2012 · Recalled
- 1 generation backK130566 BasixtouchMerit Medical Systems, Inc. · 2013
- This deviceK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943597 | Monarch AP (TM) | Merit Medical Systems, Inc. | 1995 | — |
| −4 | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2001 | 10 |
| −3 | 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 |
| −1 | K130566 | Basixtouch | Merit Medical Systems, Inc. | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K130566 | BasixtouchSummary page 6…f 5 Traditional 510(k) Premarket Notification Balloon In-Deflation Device Regulation number 870.1650 Predicate Device(s): K130566, K032840 and K993341 Device Description: The Balloon In-deflation Device is a 20ml or 30ml disposable… | 2013 |
| * | K993341 | Intellisystem II Color MonitorSummary page 6…Traditional 510(k) Premarket Notification Balloon In-Deflation Device Regulation number 870.1650 Predicate Device(s): K130566, K032840 and K993341 Device Description: The Balloon In-deflation Device is a 20ml or 30ml disposable devic… | 1999 |
| * | K032840 | Atrion Medical QL Inflation DeviceSummary page 6…Traditional 510(k) Premarket Notification Balloon In-Deflation Device Regulation number 870.1650 Predicate Device(s): K130566, K032840 and K993341 Device Description: The Balloon In-deflation Device is a 20ml or 30ml disposable… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 8 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K130566.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The Balloon In-deflation device is used for the inflation and deflation of a balloon dilatation catheter, to dilate the vessel or implant a stent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140943: Mastro Plus Balloon in-Deflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140943
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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