Cleared Traditional

K211315 - Comby EEG Caps

K211315 is an FDA 510(k) clearance for Comby EEG Caps, manufactured by Pamel D.O.O. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K211315 · Pamel D.O.O · Neurology device
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Nov 2021
Decision
193d
Days
Class 2
Risk

K211315 is an FDA 510(k) clearance for the Comby EEG Caps. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Pamel D.O.O (Zagreb, HR). The FDA issued a Cleared decision on November 9, 2021 after a review of 193 days - an extended review 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: 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.

View all Pamel D.O.O devices

FDA 510(k) Submission Details - K211315

510(k) Number K211315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date November 09, 2021
Days to Decision 193 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
45d slower than avg
Panel avg: 148d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Be-On-Quality GmbH
Stefan Bolleininger

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 187
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K211315.
Disposable EEG cable
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K213879 · Bozhou Rongjian Medical Appliance Co., Ltd. · Jan 2022
Wrap Accessory Electrodes
K210383 · Hi-Dow International, Inc. · Nov 2021
Adhesive Electrodes
K212191 · Voncare Medical Device Co., Ltd. · Oct 2021
Adhesive Electrode
K210448 · Shaoxing Yingtuo Healthcare Co., Ltd. · Aug 2021
Ceribell Instant EEG Headband
K210805 · Ceribell, Inc. · Aug 2021