510(k) · Cleared
Recalled · Class II · 2018Synchro2 Support Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on May 1, 2019 as substantially equivalent to K053268 (Boston Scientific - Precision Vascular, 2006) after a 30-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled 8 times.
- Decided
- May 1, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- MOF
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002212 (2000). 6 ancestors in all, the oldest K913074 (1991). 1 later device descends from it, 1 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 deviceK190843 Synchro2 Support GuidewireStryker · 2019
- Descendant · cites it directly · 0 of its ownK222690 SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA · 2023
Most influential descendants
Showing 1 of 1 · See all- K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA · 2023 · cites it directly0descendants
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) | K190843 | Synchro2 Support Guidewire | Stryker | 2019 | — |
| +1 | K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | 2023 | — |
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 |
|---|---|---|
| 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? (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 4…E-mail: [email protected] Date Prepared: March 29, 2019 Primary Predicate Device K053268 Synchro2 Guidewires (clearance granted 13 Mar 2006)… | 2006 |
| † | K002907 | PVS 1300 Neuro Guide Wire | 2001 |
| † | K971254 | Transend EX Platinum Guidewire | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2018 | Class II | Z-0230-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0225-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0231-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0232-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0226-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0227-2020 | Employee error | |
| Jun 8, 2018 | Class II | Z-0228-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
| Jun 8, 2018 | Class II | Z-0229-2020 | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 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, K222690 (Artiria Medical SA, 2023) has gone furthest, with 0 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. 2019, 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 Synchro2 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 as stated in the FDA summary.
https://510kreport.com/device/K190843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190843: Synchro2 Support Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190843
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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