510(k) · Cleared
ClearedZenith Micro Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Zenith Vascular SciTech Limited · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Apr 16, 2026 as substantially equivalent to K133725 (MicroVention, Inc., 2014) and 1 other predicate after a 265-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Apr 16, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K002212 (2000). 16 ancestors in all, the oldest K953533 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 6 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 5 generations backK173235 Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire…Scientia Vascular, LLC · 2018
- 4 generations backK183608 Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18…Scientia Vascular, LLC · 2019
- 3 generations backK192783 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24…Scientia Vascular, LLC · 2019
- 2 generations backK222437 Aristotle Colossus GuidewireScientia Vascular, Inc. · 2023
- 1 generation backK243938 Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24…Scientia Vascular, Inc. · 2025
- This deviceK252317 Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −6 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −5 | K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm… | Scientia Vascular, LLC | 2018 | — |
| −4 | K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| −3 | K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm… | Scientia Vascular, LLC | 2019 | — |
| −2 | K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023 | — |
| −1 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom… | Scientia Vascular, Inc. | 2025 | — |
| 0 (this device) | K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K133725 | Traxcess 14 GuidewireSummary page 5…ct Code MOF DQX Device Class Class II Traxcess 14 Guidewire (K133725) Predicate Device Aristotle 18 Guidewire (K243938) Device Description The Micro Guidew… | 2014 |
| * | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Summary page 5…Class II Traxcess 14 Guidewire (K133725) Predicate Device Aristotle 18 Guidewire (K243938) Device Description The Micro Guidewire is a non-active, surgically invasive device intended for limited duration use within… | 2025 |
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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 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. 2026, 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?
Zenith Micro Guidewire is indicated 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/K252317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252317: Zenith Micro Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252317
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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