510(k) · Cleared
Recalled · 2005Intellisystem II Color Monitor
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 Oct 25, 1999 as substantially equivalent to K884913 (Merit Medical Systems, Inc., 1989) after a 20-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 25, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884913 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884913 Merit Intelliflator (TM) & Merit Monitor (TM)Merit Medical Systems, Inc. · 1989 · Recalled
- This deviceK993341 Intellisystem II Color MonitorMerit Medical Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
- Descendant · cites it directly · 0 of its ownK050753 Stryker DiscmonitorStryker Instruments · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884913 | Merit Intelliflator (TM) & Merit Monitor (TM) | Merit Medical Systems, Inc. | 1989 | 6 |
| 0 (this device) | K993341 | Intellisystem II Color Monitor | Merit Medical Systems, Inc. | 1999 | — |
| +1 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
| +1 | K050753 | Stryker Discmonitor | Stryker Instruments | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K884913 | Merit Intelliflator (TM) & Merit Monitor (TM)Summary page 1…Inflation Device Common Name: Monitor for an Angioplasty Inflation Device Trade Name: IntelliSystem II Classification (if known): Class II, 74 MAV. Predicate Device: K884913, INTELLIFLATORm 10 Perfuormance Standards: Performance standards have not been established by the FDA under sec… | 1989 |
What descends from it? (2)
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 |
|---|---|---|---|---|
| Nov 7, 2005 | Not classified | Z-0351-06 | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. |
| Nov 7, 2005 | Not classified | Z-0348-06 | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. |
| Nov 7, 2005 | Not classified | Z-0349-06 | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. |
| Nov 7, 2005 | Not classified | Z-0350-06 | Other | Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K140943 (Beijing Demax Medical Technology Co.,Ltd, 2015) has gone furthest, with 0 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?
The Merit Medical INTELLISYSTEM II MONITOR is for use only with the disposable INITELLISYSTEMZ2S5 Syringe. It may be used to monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body.
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/K993341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993341: Intellisystem II Color Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993341
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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