Cleared Abbreviated

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162) - FDA 510(k) Clearance

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

K200162 · Wuhan Greentek Pty , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
90d
Days
Class 2
Risk

K200162 is an FDA 510(k) clearance for the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Wuhan Greentek Pty , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on April 21, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wuhan Greentek Pty , Ltd. devices

Submission Details

510(k) Number K200162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date April 21, 2020
Days to Decision 90 days
Submission Type Abbreviated
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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 436
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K200162.
BioWave BioWraps
K261522 · Biowave Corporation · Jun 2026
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
K253237 · Elde Medikal Sanayi ve Ticaret Anonim Sirketi · May 2026
MR Conditional Cup Electrodes
K254183 · Technomed Europe · May 2026
Tutamen Self Adhesive Electrodes
K252439 · Dongguan Tutamen Metalwork Co., Ltd. · May 2026
myosmart. (13E522)
K253256 · Otto Bock Healthcare Products GmbH · Apr 2026
Ceribell Brain Monitor Headband
K260363 · Ceribell, Inc. · Apr 2026