510(k) · Cleared
ClearedMerit Hydrophilic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 16, 2014 as substantially equivalent to K131710 (Merit Medical Systems, Inc., 2013) and 3 other predicates after a 211-day review. Its family tree reaches back 5 generations to 1986. 4 later devices descend from it.
- Decided
- Dec 16, 2014
- Review
- 211 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K863138 (1986). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 4 generations backK092303 Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK120644 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012 · Recalled
- 2 generations backK130588 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- 1 generation backK131710 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- This deviceK141295 Merit Hydrophilic GuidewireMerit Medical Systems, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK170933 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK201595 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK251181 Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire…Merit Medical Ireland, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK253847 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K170933Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017 · cites it directly3descendants
- K201595Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2020 · 2 generations on2descendants
- K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…Merit Medical Ireland, Ltd. · 2025 · 3 generations on1descendant
- K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −4 | K092303 | Merit Laureate Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2009 | 6 |
| −3 | K120644 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2012 | 2 |
| −2 | K130588 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| −1 | K131710 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K141295 | Merit Hydrophilic Guidewire | Merit Medical Systems, Inc. | 2014 | — |
| +1 | K170933 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
| +2 | K201595 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2020 | 1 |
| +3 | K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic… | Merit Medical Ireland, Ltd. | 2025 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | K131710 | Merit Hydrophilic Guide WireSummary page 4…Classification Name: Catheter Guide Wire Premarket Notification Predicate Device # 1: Merit Hydrophilic Guide Wire K131710 Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 2:… | 2013 |
| * | K130588 | Merit Hydrophilic Guide WireSummary page 4…Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 2: Merit Hydrophilic Guide Wire K130588 Predicate Manufacturer: Merit Medical Systems, Inc Device Premarket Notification Predicate Device # 3:… | 2013 |
| * | K123609 | Merit Hydrophilic Guide WireSummary page 4…Predicate Manufacturer: Merit Medical Systems, Inc Device Premarket Notification Predicate Device # 3: Merit Hydrophilic Guide Wire K123609 Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 4:… | 2013 |
| * | K120644 | Merit Hydrophilic Guide WireSummary page 4…Manufacturer: Merit Medical Systems, Inc Premarket Notification Predicate Device # 4: Merit Hydrophilic Guide Wire K120644 Manufacturer: Merit Medical Systems, Inc Class II 21 CFR § 870.1330 C… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170933 | Merit Hydrophilic Guide Wire | 2017 | 3 |
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 28 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K170933 (Merit Medical Systems, Inc., 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141295: Merit Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141295
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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