Cleared Traditional

K243383 - CHIKAI Nexus 014 (FDA 510(k) Clearance)

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

K243383 · Asahi Intecc Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
172d
Days
Class 2
Risk

K243383 is an FDA 510(k) clearance for the CHIKAI Nexus 014. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on April 21, 2025 after a review of 172 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - 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. Standard predicate reliance. 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 Asahi Intecc Co., Ltd. devices

Submission Details

510(k) Number K243383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2024
Decision Date April 21, 2025
Days to Decision 172 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
24d slower than avg
Panel avg: 148d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 Consultant

Asahi Intecc USA, Inc.
Cynthia Valenzuela

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

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