510(k) · Cleared
ClearedTraxcess Pro 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 Dec 29, 2015 as substantially equivalent to K133725 (MicroVention, Inc., 2014) after a 70-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 29, 2015
- Review
- 70 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953533 (1995). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK953533 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1995
- 4 generations backK961445 Radifocus Glidewire for Coronary Use with Platinum (or Gold) CoilTerumo Medical Corp. · 1996
- 3 generations backK063695 Runthrough NSTerumo Medical Corp. · 2007 · Recalled
- 2 generations backK080863 Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc. · 2008
- 1 generation backK133725 Traxcess 14 GuidewireMicroVention, Inc. · 2014
- This deviceK153053 Traxcess Pro 14 GuidewireMicroVention, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK161803 Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK201487 Traxcess 7 Mini GuidewireMicroVention, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK200547 Traxcess 14 SELECT GuidewireMicroVention, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK163154 Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K161803Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016 · cites it directly2descendants
- K201487Traxcess 7 Mini GuidewireMicroVention, Inc. · 2020 · 2 generations on0descendants
- K200547Traxcess 14 SELECT GuidewireMicroVention, Inc. · 2020 · cites it directly0descendants
- K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953533 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1995 | — |
| −4 | K961445 | Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil | Terumo Medical Corp. | 1996 | — |
| −3 | K063695 | Runthrough NS | Terumo Medical Corp. | 2007 | 1 |
| −2 | K080863 | Traxcess 0.014 Hydrophilic Guidewire | MicroVention, Inc. | 2008 | — |
| −1 | K133725 | Traxcess 14 Guidewire | MicroVention, Inc. | 2014 | — |
| 0 (this device) | K153053 | Traxcess Pro 14 Guidewire | MicroVention, Inc. | 2015 | — |
| +1 | K161803 | Traxcess .007 Mini Guidewire | MicroVention, Inc. | 2016 | 1 |
| +2 | K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020 | — |
| +1 | K200547 | Traxcess 14 SELECT Guidewire | MicroVention, Inc. | 2020 | — |
| +2 | K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K133725 | Traxcess 14 GuidewireSummary page 4…Division of Cardiovascular Devices (Office of Device Evaluation, CDRH) III. PREDICATE DEVICE [807.92(a)(3)] Traxcess 14 Guidewire (K133725) IV. DEVICE DESCRIPTION [807.92(a)(4)] The Traxcess® Pro 14 Guidewire is a coiled wire that is designed to fit inside a per… | 2014 |
What descends from it? (4)
2 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 20 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K161803 (MicroVention, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K133725.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® Pro 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/K153053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153053: Traxcess Pro 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/K153053
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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