510(k) · Cleared
ClearedSilverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic Guidewire, Mirage HY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 7, 2013 as substantially equivalent to K982543 (Micro Therapeutics, Inc., 1998) and 4 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Mar 7, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K982543 (1998). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK982543 Silverstreak Hydrophilic GuidewireMicro Therapeutics, Inc. · 1998 · Recalled
- This deviceK124007 Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange…Micro Therapeutics, Inc. D/B/A: Ev3, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK193548 Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
- Descendant · 2 generations on · 0 of its ownK201690 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
Most influential descendants
Showing 2 of 2 · See all- K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · cites it directly1descendant
- K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982543 | Silverstreak Hydrophilic Guidewire | Micro Therapeutics, Inc. | 1998 | 1 |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K982543 | Silverstreak Hydrophilic GuidewireSummary page 1…DOX, Class 11 Predicate Micro Therapeutics, Inc. d/bla ev3 Neurovasciilar, Device: SilverSpeed Tm Hydrophilic Guidewire K982543 K993257 X-celerator Tm Hydr… | 1998 |
| * | K993257 | .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016…Summary page 1…, Device: SilverSpeed Tm Hydrophilic Guidewire K982543 K993257 X-celerator Tm Hydrophilic Exchange Guidewire K01 0497… | 1999 |
| * | K010497 | Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300Summary page 1…3 K993257 X-celerator Tm Hydrophilic Exchange Guidewire K01 0497 4 Originally, cleared under trade name: Silve… | 2001 |
| * | K001454 | Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145CM Length, Support) Silverspeed…Summary page 1…ally, cleared under trade name: SilverSpeed" Hydrophilic Guidewire X-pedion Tm Hydrophilic Guidewire K001454 Originally, cleared under trade name: SilverSpeed Hydrophilic Guidewire… | 2000 |
| * | K002212 | Mirage Hydrophilic Guidewire, Model 103-0608Summary page 1…nally, cleared under trade name: SilverSpeed Hydrophilic Guidewire Mirage Tm Hydrophilic Guidewire K00221 2 9124007,rr2 43 Device The Hydrophilic Guid… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire | 2020 | 1 |
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?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SilverSpeed™, Mirage™, X-celerator™ Exchange and X-pedion™ Hydrophilic Guidewires are 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/K124007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124007: Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic Guidewire, Mirage HY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124007
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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