510(k) · Decided
Recalled · Class II · 2024DiamondTOUCH Inflation Device and 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 Jul 29, 2016 as substantially equivalent to K011811 (Merit Medical Systems, Inc., 2001) after a 192-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 29, 2016
- Review
- 192 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943597 (1995). 3 ancestors in all. 1 later device descends 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 deviceK160107 DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK260035 Digital Indeflator INFLANTEUAB Telemedicina · 2026
Most influential descendants
Showing 1 of 1 · See all- K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026 · cites it directly0descendants
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) | K160107 | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Merit Medical Systems, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K011811 | Monarch Inflation Syringe; Universal Fluid Dispensing SyringeSummary page 4…ngiographic (DXT) Predicate Subsequent Device Classification Name: Syringe, Balloon Inflation (MAV) Premarket Notification: K011811 Manufacturer: Merit Medical Systems, Inc. This predicate has not been subject… | 2001 |
| † | K130566 | Basixtouch | 2013 |
| † | K083523 | Monarch Compak Inflation Syringe and Universal Fluid Dispensing Syringe | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260035 | Digital Indeflator INFLANTE | 2026 | 0 |
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-0066-2025 | 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 21 years and passes through 1 company; a new generation was cleared every 14.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K260035 (UAB Telemedicina, 2026) has gone furthest, with 0 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. 2016, 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 DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation 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/K160107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160107: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160107
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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