Cleared Traditional

EZ-STIK Electrodes (K223775) - FDA 510(k) Clearance

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

K223775 · South Dakota Partners · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
18d
Days
Class 2
Risk

K223775 is an FDA 510(k) clearance for the EZ-STIK Electrodes. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by South Dakota Partners (Clear Lake, US). The FDA issued a Cleared decision on January 3, 2023 after a review of 18 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all South Dakota Partners devices

Submission Details

510(k) Number K223775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2022
Decision Date January 03, 2023
Days to Decision 18 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

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 97
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K223775.
Disposable Non-invasive EEG Sensor
K220448 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jan 2023
Self-adhesive Electrode
K222252 · Shenzhen Roundwhale Technology Co. , Ltd. · Jan 2023
Alpha Control Liner System (ACLS)
K223738 · Coapt · Jan 2023
ControlSeal Electrode (ELSB)
K223605 · Coapt · Dec 2022
Self-adhesive Electrode
K222453 · Guangdong Comytens Medical Technology Co., Ltd. · Nov 2022
Dexus Prosthetics System (Model: MSL1, MSR1)
K220002 · Zhejiang Qiangnao Technology Co.,Ltd · Sep 2022