510(k) · Cleared
ClearedAgility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM & XL 350CM, Agility 16 Standard &
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Feb 24, 2014 as substantially equivalent to K121776 (Codman & Shurtleff, Inc., 2012) after a 90-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Feb 24, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991646 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK991646 Agility Steerable GuidewireCordis Neurovascular, Inc. · 1999
- 2 generations backK100351 Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010
- 1 generation backK121776 Agility Steerable Guidewire Neuroscout Steerable GudiewireCodman & Shurtleff, Inc. · 2012
- This deviceK133625 Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard &…Codman & Shurtleff, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991646 | Agility Steerable Guidewire | Cordis Neurovascular, Inc. | 1999 | — |
| −2 | K100351 | Neuroscout Steerable Guidewire | Codman & Shurtleff, Inc. | 2010 | — |
| −1 | K121776 | Agility Steerable Guidewire Neuroscout Steerable Gudiewire | Codman & Shurtleff, Inc. | 2012 | — |
| 0 (this device) | K133625 | Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN… | Codman & Shurtleff, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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 MOF? 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 MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 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 |
|---|---|---|---|
| * | K121776 | Agility Steerable Guidewire Neuroscout Steerable GudiewireSummary page 2…ging Change: Guidewires AGILITY® Steerable NEUROSCOUT9 (K121776) Guidewire Steerable Guidewire The Cadman AGILITY' and… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
The AGILITY® Steerable Guidewires are intended for selective placement of microcatheters and other devices in the nero, and peripheral vasculature.
The NEUROSCOUT®1 Steerable Guidewires are intended for selective placement of niicrocalhcters and other devices in the neuro and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133625: Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM & XL 350CM, Agility 16 Standard &.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133625
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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