Cleared Special

K192568 - Jiajian Self-Adhesive Electrode (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192568 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology device
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Feb 2021
Decision
504d
Days
Class 2
Risk

K192568 is an FDA 510(k) clearance for the Jiajian Self-Adhesive Electrode. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on February 3, 2021 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Wuxi Jiajian Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K192568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2019
Decision Date February 03, 2021
Days to Decision 504 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
356d slower than avg
Panel avg: 148d · This submission: 504d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - GXY Electrode, Cutaneous

All 433
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