510(k) · Cleared

Cleared

Viradius Neurowire

K151825510(k) TraditionalCleared Nov 16, 2015133-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mivi Neuroscience, Inc. · MOF Guide, Wire, Catheter, Neurovasculature

Cleared on Nov 16, 2015 as substantially equivalent to K100351 (Codman & Shurtleff, Inc., 2010) after a 133-day review. Its family tree reaches back 2 generations to 1999.

Decided: Nov 16, 2015
Review: 133 days
Class: Class II
Product code: MOF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K991646 (1999). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK991646 Agility Steerable GuidewireCordis Neurovascular, Inc. · 1999
1 generation backK100351 Neuroscout Steerable GuidewireCodman & Shurtleff, Inc. · 2010
This deviceK151825 Viradius NeurowireMivi Neuroscience, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K991646	Agility Steerable Guidewire	Cordis Neurovascular, Inc.	1999	—
−1	K100351	Neuroscout Steerable Guidewire	Codman & Shurtleff, Inc.	2010	—
0 (this device)	K151825	Viradius Neurowire	Mivi Neuroscience, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0

FIG. 1 — Lineage of K151825, 1999–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K100351	Neuroscout Steerable Guidewire Summary page 4 …21 CFR 870.1330 – Class II Product Code: MOF - Primary DQX - Secondary Predicate Device: NeuroScout Steerable Guidewire, 510(k)#: K100351 Performance Data: The following bench testing was performed in support of the Viradius Neurowire and t…	Codman & Shurtleff, Inc.	2010	—

Also cleared against K100351: 1 other device →

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 16 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K100351.

How does its category compare?

All MOF devices

MOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MOF

11so far in 2026, the most since 2007

2007high 11 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOF

172in 2025

2007high 199 (2023) · low 36 (2020)2026

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

2007high 135 (2025) · low 0 (2007)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	MAUDE reports
2007	0	—	0
2008	0	—	1
2009	0	—	0
2010	0	—	0
2011	2	—	0
2012	0	—	2
2013	0	—	2
2014	2	—	0
2015	3	133	5
2016	4	61	3
2017	1	—	15
2018	2	—	11
2019	4	58	12
2020	4	36	18
2021	0	—	39
2022	1	—	92
2023	4	199	91
2024	2	—	95
2025	5	172	135
2026	11	192	—

What is it indicated for?

The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.

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/K151825 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151825: Viradius Neurowire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151825

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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