510(k) · Cleared
ClearedSplashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Ireland, Ltd. · DQX Wire, Guide, Catheter
Cleared on Jan 31, 2026 as substantially equivalent to K251181 (Merit Medical Ireland, Ltd., 2025) after a 60-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Jan 31, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K863138 (1986). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 5 generations between
- 3 generations backK170933 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017
- 2 generations backK201595 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2020 · Recalled
- 1 generation backK251181 Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire…Merit Medical Ireland, Ltd. · 2025
- This deviceK253847 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 8 generations backK092303 Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · Recalled
- 7 generations backK120644 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · Recalled
- 6 generations backK130588 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- 5 generations backK131710 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- 4 generations backK141295 Merit Hydrophilic GuidewireMerit Medical Systems, Inc. · 2014
- 3 generations backK170933 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017
- 2 generations backK201595 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2020 · Recalled
- 1 generation backK251181 Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire…Merit Medical Ireland, Ltd. · 2025
- This deviceK253847 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −8 | K092303 | Merit Laureate Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2009 | 6 |
| −7 | K120644 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2012 | 2 |
| −6 | K130588 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| −5 | K131710 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| −4 | K141295 | Merit Hydrophilic Guidewire | Merit Medical Systems, Inc. | 2014 | — |
| −3 | K170933 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
| −2 | K201595 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2020 | 1 |
| −1 | K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic… | Merit Medical Ireland, Ltd. | 2025 | — |
| 0 (this device) | K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2013 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…Summary page 7…Catheter Regulation Number: 21 CFR 870.1330 Regulation Medical Specialty Cardiovascular Premarket Notification: K251181 Predicate Manufacturer: Merit Medical Systems Inc. Device The Splashwire Hydrophilic guide… | 2025 |
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 40 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
Contraindications: These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the Neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253847
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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