510(k) · Cleared
ClearedTraxcess 14 Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Jul 31, 2014 as substantially equivalent to K080863 (MicroVention, Inc., 2008) after a 237-day review. Its family tree reaches back 4 generations to 1995. 9 later devices descend from it.
- Decided
- Jul 31, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953533 (1995). 6 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 3 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 2 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 1 generation backK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- This deviceK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK153053 Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK161803 Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK182337 HYBRID GuidewireBalt USA, LLC · 2018
- Descendant · cites it directly · 0 of its ownK252317 Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026
- Descendant · 2 generations on · 0 of its ownK252011 CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K153053Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015 · cites it directly4descendants
- K161803Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · 2 generations on2descendants
- K182337HYBRID GuidewireBalt USA, LLC · 2018 · cites it directly1descendant
- K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026 · cites it directly0descendants
- K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −3 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −2 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −1 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| 0 (this device) | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| +1 | K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015 | — |
| +2 | K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016 | 1 |
| +1 | K182337 | HYBRID Guidewire | Balt USA, LLC | 2018 | — |
| +1 | K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026 | — |
| +2 | K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2026 | 2 | 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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 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 |
|---|---|---|---|
| * | K080863 | Traxcess 0.014 Hydrophilic GuidewireSummary page 1…Naomi Gong Date: December 4, 2013 Predicate Device: Number Description Clearance Date K080863 . Traxcess 0.0 14" H-ydrophilic April 7, 2008 Cu idew ire Device Descr… | 2008 |
What descends from it? (9)
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)
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 19 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K153053 (MicroVention, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K080863.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133725: Traxcess 14 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133725
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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