Cleared Special

K262654 - Dexus Prosthetic System (MSL2, MSR2)

K262654 is an FDA 510(k) clearance for Dexus Prosthetic System (MSL2, manufactured by Zhejiang Qiangnao Technology Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Special 510(k) pathway after a 28-day FDA review.

K262654 · Zhejiang Qiangnao Technology Co.,Ltd · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
28d
Days
Class 2
Risk

K262654 is an FDA 510(k) clearance for the Dexus Prosthetic System (MSL2, MSR2). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Zhejiang Qiangnao Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on August 27, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262654

510(k) Number K262654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2026
Decision Date August 27, 2026
Days to Decision 28 days
Submission Type Special
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
121d faster than avg
Panel avg: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 439
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K262654 · Dexus Prosthetic System (MSL2, MSR2)
Download PDF FDA Summary Zhejiang Qiangnao Tec…