510(k) · Cleared
ClearedDCwire Micro-guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Achieva Medical Suzhou Co., Ltd. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Mar 16, 2026 as substantially equivalent to K202522 (Stryker Neurovascular, 2020) and 1 other predicate after a 252-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 16, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002212 (2000). 7 ancestors in all, the oldest K913074 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK002212 Mirage Hydrophilic Guidewire, Model 103-0608Micro Therapeutics, Inc. · 2000
- 4 generations backK032146 PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc. · 2003 · Recalled
- 3 generations backK050964 PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular · 2005 · Recalled
- 2 generations backK053268 PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular · 2006 · Recalled
- 1 generation backK202522 Synchro SELECT GuidewireStryker Neurovascular · 2020 · Recalled
- This deviceK252122 DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608 | Micro Therapeutics, Inc. | 2000 | — |
| −4 | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | 2003 | 1 |
| −3 | K050964 | PV 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | 2005 | 6 |
| −2 | K053268 | PVS 2000 SYNCHRO2 Guidewire | Boston Scientific - Precision Vascular | 2006 | 13 |
| −1 | K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020 | 1 |
| 0 (this device) | K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K202522 | Synchro SELECT GuidewireSummary page 5…R 870.1330 – Class II Product Code: MOF, DQX Legally Marketed Predicate Devices Primary Predicate Device K202522 Synchro SELECT™ Guidewire Predicate Device K032146 PVS… | 2020 |
| * | K032146 | PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresSummary page 5…Primary Predicate Device K202522 Synchro SELECT™ Guidewire Predicate Device K032146 PVS 1300 Synchro® 0.014” & PVS 1600 Synchro® 0.010” Guidewires Dev… | 2003 |
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 3.0 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K202522.
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?
The DCwire Micro-guidewire is intended for general intravascular use, including neuro and peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252122: DCwire 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/K252122
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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