510(k) · Cleared
ClearedLunderquist Extra Stiff Wire Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William Cook Europe Aps · DQX Wire, Guide, Catheter
Cleared on Feb 17, 2022 as substantially equivalent to K171513 (William Cook Europe Aps, 2017) after a 30-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Feb 17, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K061670 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK061670 Lunderquist Wire Guide; DC Wire GuideWilliam Cook Europe Aps · 2007
- 1 generation backK171513 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2017
- This deviceK220137 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2022
- Descendant · cites it directly · 0 of its ownK251596 Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2025
- Descendant · cites it directly · 0 of its ownK230418 Mighty Wire Guide WireMerit Medical Systems, Inc. · 2023
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 | K061670 | Lunderquist Wire Guide; DC Wire Guide | William Cook Europe Aps | 2007 | — |
| −1 | K171513 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2017 | — |
| 0 (this device) | K220137 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2022 | — |
| +1 | K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | 2025 | — |
| +1 | K230418 | Mighty Wire Guide Wire | Merit Medical Systems, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K171513 | Lunderquist Extra Stiff Wire GuideSummary page 5…e 1 of 3 K220137 Predicate Devices: The subject devices are substantially equivalent to the predicate devices, the Lunderquist® Extra Stiff Wire Guides (K171513, cleared 07 December 2017). Comparison to Predicate Device: The subject Lunderquist® Extra Stiff Wire Guides are substantially… | 2017 |
What descends from it? (2)
2 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?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K251596 (William Cook Europe Aps, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220137 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220137: Lunderquist Extra Stiff Wire Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220137
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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