510(k) · Cleared
ClearedEndologix 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 Feb 25, 2011 as substantially equivalent to K053251 (Techdevice Corporation, 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Feb 25, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013723 (2002). 6 ancestors in all, the oldest K933334 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK013723 Modification to: Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2002 · Recalled
- 1 generation backK053258 Eub-6500 Diagnostic Ultrasound ScannerHitachi Medical Corp. · 2005
- This deviceK110241 Endologix GuidewireTechdevice Corporation · 2011
- Descendant · cites it directly · 1 of its ownK152177 SonoStik IV Guide Wire IntroducerSonostik, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK243061 SonoStik Guide Wire IntroducerSonostik, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013723 | Modification to: Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2002 | 2 |
| −1 | K053258 | Eub-6500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | 2005 | — |
| 0 (this device) | K110241 | Endologix Guidewire | Techdevice Corporation | 2011 | — |
| +1 | K152177 | SonoStik IV Guide Wire Introducer | Sonostik, LLC | 2015 | — |
| +2 | K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K053251 | Techdevice GuidewireSummary page 1…Common Name: Guldewire Classification: DCX, Catheter guide wire 21 CFR 870. 1330 Predicate Devices Guidewire K053251 TechDevice Corporation Watertown, MA 02472 Guidewire K(053028 TechDevice Corporati… | 2006 |
| * | K053258 | Eub-6500 Diagnostic Ultrasound ScannerSummary page 2…bstantial Equivalence The proposed guidewires ame substantially equivalent to the currently marketed guidewires which were cleared for marketing by FDA under K053251 and K053258. Substantial equivalence for the proposed devices is based on a compaison of materials, dimensional specifications, design charac… | 2005 |
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 |
|---|---|---|---|
| K152177 | SonoStik IV Guide Wire Introducer | 2015 | 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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K152177 (Sonostik, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K053251.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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/K110241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110241: Endologix Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110241
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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