510(k) · Cleared
Recalled · Class II · 2014Merit Hydrophilic Guide Wire
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 Sep 19, 2012 as substantially equivalent to K092303 (Merit Medical Systems, Inc., 2009) after a 201-day review. Its family tree reaches back 2 generations to 1986. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 19, 2012
- Review
- 201 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K863138 (1986). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 1 generation backK092303 Merit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc. · 2009 · Recalled
- This deviceK120644 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK130588 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK131710 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK123609 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK141295 Merit Hydrophilic GuidewireMerit Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK170933 Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130588Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · cites it directly6descendants
- K131710Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · cites it directly5descendants
- K123609Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2013 · cites it directly5descendants
- K141295Merit Hydrophilic GuidewireMerit Medical Systems, Inc. · 2014 · cites it directly4descendants
- K170933Merit Hydrophilic Guide WireMerit Medical Systems, Inc. · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −1 | K092303 | Merit Laureate Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2009 | 6 |
| 0 (this device) | K120644 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2012 | — |
| +1 | K130588 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K131710 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K123609 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K141295 | Merit Hydrophilic Guidewire | Merit Medical Systems, Inc. | 2014 | — |
| +2 | K170933 | Merit Hydrophilic Guide Wire | Merit Medical Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K092303 | Merit Laureate Hydrophilic Guide WireSummary page 1…Merit Hydrophilic Guide Wire Predicate Classification Name: Catheter Guide Wire Devices Premarket Notification: K092303 Manufacturer: Merit Medical Systems, Inc. Class 11 Classifi… | 2009 |
What descends from it? (8)
4 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 |
|---|---|---|---|---|
| Apr 14, 2014 | Class II | Z-1485-2014 | Process control | Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of… |
| Apr 14, 2014 | Class II | Z-1486-2014 | Process control | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 22.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K130588 (Merit Medical Systems, Inc., 2013) has gone furthest, with 6 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. 2012, 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 facilitate the placement of devices during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120644: Merit Hydrophilic Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120644
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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