510(k) · Cleared
ClearedTechdevice Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techdevice Corporation · DQX Wire, Guide, Catheter
Cleared on Mar 8, 2006 as substantially equivalent to K943737 (Boston Scientific Corp, 1994) and 2 other predicates after a 107-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Mar 8, 2006
- Review
- 107 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K933334 (1994). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK933334 Magic Torque GuidewireBoston Scientific Corp · 1994 · Recalled
- This deviceK053251 Techdevice GuidewireTechdevice Corporation · 2006
- Descendant · cites it directly · 2 of its ownK110241 Endologix GuidewireTechdevice Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
- Descendant · cites it directly · 0 of its ownK141218 Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire…Vadiswire Corporation · 2014
- Descendant · cites it directly · 0 of its ownK094062 Percu-Pro GuidewireCardiosolutions, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K110241Endologix GuidewireTechdevice Corporation · 2011 · cites it directly2descendants
- K152177SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015 · 2 generations on1descendant
- K243061SonoStik Guide Wire IntroducerSonostik, LLC · 2024 · 3 generations on0descendants
- K141218Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire SystemVadiswire Corporation · 2014 · cites it directly0descendants
- K094062Percu-Pro GuidewireCardiosolutions, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933334 | Magic Torque Guidewire | Boston Scientific Corp | 1994 | 1 |
| 0 (this device) | K053251 | Techdevice Guidewire | Techdevice Corporation | 2006 | — |
| +1 | K110241 | Endologix Guidewire | Techdevice Corporation | 2011 | — |
| +2 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +3 | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
| +1 | K141218 | Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire System | Vadiswire Corporation | 2014 | — |
| +1 | K094062 | Percu-Pro Guidewire | Cardiosolutions, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K943737 | Microvasive Pathfinder Exchange Guidewire Insurg Pathfinder GuidewireSummary page 1…ewire Common Name: Guidewire Classification: DQX, Catheter guide wire 21 CFR 870. 1330 Predicate Devices Guidewvire K943737 Boston Scientific Corporation Natick, MA 01 760… | 1994 |
| * | K935997 | Platinum Plus GuidewireSummary page 1…s Guidewvire K943737 Boston Scientific Corporation Natick, MA 01 760 Guidewire K935997 Boston Scientific Corporation Natick, MA 01 760… | 1994 |
| * | K933334 | Magic Torque GuidewireSummary page 1…Guidewire K935997 Boston Scientific Corporation Natick, MA 01 760 Guidewvire K933334 Boston Scientific Corporation Natick, MA 0 1760 Product Description:… | 1994 |
What descends from it? (5)
3 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)
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.
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 TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053251: Techdevice Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053251
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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