510(k) · Cleared
ClearedModification to: Agility Steerable Guidewires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 1, 2001 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 1, 2001
- Review
- 8 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK010511 Modification to: Agility Steerable GuidewiresCordis Neurovascular, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK100351 Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121776 Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK151825 Viradius NeurowireMivi Neuroscience, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK133625 Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard &…Codman & Shurtleff, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K100351Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010 · cites it directly3descendants
- K121776Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012 · cites it directly1descendant
- K151825Viradius NeurowireMivi Neuroscience, Inc. · 2015 · 2 generations on0descendants
- K133625Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM &…Codman & Shurtleff, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010511 | Modification to: Agility Steerable Guidewires | Cordis Neurovascular, Inc. | 2001 | — |
| +1 | K100351 | Neuroscout Steerable Guidewire | Codman & Shurtleff, Inc. | 2010 | — |
| +1 | K121776 | Agility Steerable Guidewire Neuroscout Steerable Gudiewire | Codman & Shurtleff, Inc. | 2012 | — |
| +2 | K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015 | — |
| +2 | K133625 | Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN… | Codman & Shurtleff, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K100351 (Codman & Shurtleff, Inc., 2010) has gone furthest, with 3 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.
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) | — |
https://510kreport.com/device/K010511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010511: Modification to: Agility Steerable Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010511
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026