510(k) · Cleared
Cleared14 Wire Standard, 14 Wire LS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. · DQX Wire, Guide, Catheter
Cleared on Feb 24, 2012 as substantially equivalent to K971254 (Boston Scientific Corp, 1997) and 1 other predicate after a 95-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 24, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964611 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964611 Transend GuidewireBoston Scientific Corp · 1997
- This deviceK113454 14 Wire Standard, 14 Wire LSMicro Therapeutics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964611 | Transend Guidewire | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K113454 | 14 Wire Standard, 14 Wire LS | Micro Therapeutics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K971254 | Transend EX Platinum GuidewireSummary page 1…eter Guidewire Device: Classification of DOX, Catheter Guidewire (21 CFR 870.1330), Class If Device: Predicate Devices: 0.014" Transend EX Platinum Guidewire (K971254) 0.014g Transend EX Guidewire (K96461 1) Device The 14 Wire is a stainless steel guidewire… | 1997 |
| * | K964611 | Transend GuidewireSummary page 1…uidewire (21 CFR 870.1330), Class If Device: Predicate Devices: 0.014" Transend EX Platinum Guidewire (K971254) 0.014g Transend EX Guidewire (K96461 1) Device The 14 Wire is a stainless steel guidewire with a radiopaque Description: distal segment. The d… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K971254.
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 14 Wire Hydrophilic Guidewire is indicated far general use to aid in the selective placement of catheters inthe peripheral and cerebral intravascular during diagnostic and/or therapeutic procedures. The device is not intended for vasculature use in the coronary arteries.
The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113454: 14 Wire Standard, 14 Wire LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113454
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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