510(k) · Cleared
ClearedMirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQX Wire, Guide, Catheter
Cleared on Jul 21, 2020 as substantially equivalent to K193548 (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 2020) after a 29-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jul 21, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982543 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK982543 Silverstreak Hydrophilic GuidewireMicro Therapeutics, Inc. · 1998 · Recalled
- 2 generations backK124007 Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013
- 1 generation backK193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
- This deviceK201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982543 | Silverstreak Hydrophilic Guidewire | Micro Therapeutics, Inc. | 1998 | 1 |
| −2 | K124007 | Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire… | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | 2013 | — |
| −1 | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
| 0 (this device) | K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireSummary page 4…r Guide Wire Description: Device Classification: Class II Predicate Device: Mirage™ and X-pedion™ Hydrophilic Guidewires 510(k): K193548 Reference Device: React™ 68 Catheter 510(k): K180715 Device Description: The Hydrophilic Gui… | 2020 |
| † | K180715 | React 68 Catheter | 2018 |
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 22 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201690 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201690: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201690
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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