Cleared Traditional

K262214 - Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)

K262214 is an FDA 510(k) clearance for Disposable Reflective Marker Spheres (A..., manufactured by Guangzhou Aimooe Technology Co., Ltd.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K262214 · Guangzhou Aimooe Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
107d
Days
Class 2
Risk

K262214 is an FDA 510(k) clearance for the Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Guangzhou Aimooe Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on October 15, 2026 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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.

FDA 510(k) Submission Details - K262214

510(k) Number K262214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2026
Decision Date October 15, 2026
Days to Decision 107 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
42d faster than avg
Panel avg: 149d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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

Share Info (Guangzhou) Medical Consultant , Ltd.
Cassie Lee

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 - HAW Neurological Stereotaxic Instrument

All 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K262214.
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K262214 · Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
Download PDF FDA Summary Guangzhou Aimooe Tech…