Cleared Traditional

K230006 - Ankyras (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230006 · Mentice Spain S.L. · Neurology device
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Dec 2023
Decision
359d
Days
Class 2
Risk

K230006 is an FDA 510(k) clearance for the Ankyras. Classified as Software For Visualization Of Vascular Anatomy And Intravascular Devices (product code PZO), Class II - Special Controls.

Submitted by Mentice Spain S.L. (Barcelona, ES). The FDA issued a Cleared decision on December 28, 2023 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 892.2050 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mentice Spain S.L. devices

Submission Details

510(k) Number K230006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2023
Decision Date December 28, 2023
Days to Decision 359 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 148d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices

All 9
Devices cleared under the same product code (PZO) and FDA review panel - the closest regulatory comparables to K230006.
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K253122 · Sim&Cure · Dec 2025
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K250160 · Mentice Spain S.L. · May 2025
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K242124 · Sim&Cure · Dec 2024
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K222664 · Sim&Cure · Jan 2023
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K213838 · ArteryFlow Technology Co., Ltd. · Jun 2022
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K212373 · Sim&Cure · Jan 2022