510(k) · Cleared
Recalled · Class II · 2024Synchro SELECT Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Sep 25, 2020 as substantially equivalent to K053268 (Boston Scientific - Precision Vascular, 2006) after a 24-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 2020
- Review
- 24 days
- Class
- Class II
- Product code
- MOF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002212 (2000). 6 ancestors in all, the oldest K913074 (1991). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 3 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 2 generations backK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
- 1 generation backK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled
- This deviceK202522 Synchro SELECT GuidewireStryker Neurovascular · 2020
- Descendant · cites it directly · 4 of its ownK243756 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 2 generations on · 3 of its ownK253168 0.014” Willow GuidewireArbor Endovascular, LLC · 2025
- Descendant · 3 generations on · 1 of its ownK260130 Willow 18 GuidewireArbor Endovascular, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK262424 Willow 12 GuidewireArbor Endovascular, LLC · 2026
- Descendant · 4 generations on · 0 of its ownK260537 Willow 24 GuidewireArbor Endovascular, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K2437560.014” Willow GuidewireArbor Endovascular, LLC · 2025 · cites it directly4descendants
- K2531680.014” Willow GuidewireArbor Endovascular, LLC · 2025 · 2 generations on3descendants
- K260130Willow 18 GuidewireArbor Endovascular, LLC · 2026 · 3 generations on1descendant
- K262424Willow 12 GuidewireArbor Endovascular, LLC · 2026 · 3 generations on0descendants
- K260537Willow 24 GuidewireArbor Endovascular, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −3 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −2 | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | 6 |
| −1 | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | 13 |
| 0 (this device) | K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020 | — |
| +1 | K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +2 | K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025 | — |
| +3 | K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026 | — |
| +3 | K262424 | Willow 12 Guidewire | Arbor Endovascular, LLC | 2026 | — |
| +4 | 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 |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K053268 | PVS 2000 SYNCHRO2 GuidewireSummary page 5…ascular Premarket Notification, Special 510(k) Synchro SELECT Guidewire Legally Marketed Predicate Device Primary Predicate Device K053268* PV 2000 Synchro2 Guidewire… | 2006 |
| † | K190843 | Synchro2 Support Guidewire | 2019 |
| † | K971254 | Transend EX Platinum Guidewire | 1997 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2024 | Class II | Z-1940-2024 | Component design/selection | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K243756 (Arbor Endovascular, LLC, 2025) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K053268.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Synchro SELECT Guidewire series 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 neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202522: Synchro SELECT Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202522
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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