510(k) · Cleared
Cleared0.014” Willow Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbor Endovascular, LLC · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Nov 26, 2025 as substantially equivalent to K243756 (Arbor Endovascular, LLC, 2025) after a 61-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Nov 26, 2025
- Review
- 61 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002212 (2000). 8 ancestors in all, the oldest K913074 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 5 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 4 generations backK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
- 3 generations backK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled
- 2 generations backK202522 Synchro SELECT GuidewireStryker Neurovascular · 2020 · Recalled
- 1 generation backK243756 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- This deviceK253168 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · cites it directly · 1 of its ownK260130 Willow 18 GuidewireArbor Endovascular, LLC · 2026
- Descendant · cites it directly · 0 of its ownK262424 Willow 12 GuidewireArbor Endovascular, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK260537 Willow 24 GuidewireArbor Endovascular, LLC · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −5 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −4 | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | 6 |
| −3 | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | 13 |
| −2 | K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020 | 1 |
| −1 | K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| 0 (this device) | K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +1 | K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026 | — |
| +1 | K262424 | Willow 12 Guidewire | Arbor Endovascular, LLC | 2026 | — |
| +2 | K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 3 | 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 K243938 Aristotle 14 Guidewire; Aristotle 18…score 16.6 · 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 |
|---|---|---|---|
| * | K243756 | 0.014” Willow GuidewireSummary page 5…FR 870.1330 – Class II Product Code: MOF, DQX Legally Marketed Predicate Device: 0.014” Willow™ Guidewire (K243756) Device Description: Like the predicate device, the 0.014” Willow Guidewire is a single-use product with a shapeable tip avail… | 2025 |
What descends from it? (3)
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 25 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K260130 (Arbor Endovascular, LLC, 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 0.014” Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253168: 0.014” Willow Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253168
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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