Cleared Traditional

K042301 - PROTENS ELECTRODE

K042301 is an FDA 510(k) clearance for PROTENS ELECTRODE, manufactured by Bio Protech, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K042301 · Bio Protech, Inc. · Neurology device
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Sep 2004
Decision
9d
Days
Class 2
Risk

K042301 is an FDA 510(k) clearance for the PROTENS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Crofton, US). The FDA issued a Cleared decision on September 3, 2004 after a review of 9 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 Bio Protech, Inc. devices

FDA 510(k) Submission Details - K042301

510(k) Number K042301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2004
Decision Date September 03, 2004
Days to Decision 9 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 148d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Entela, Inc.
NED DEVINE

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 290
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K042301.
EVERLIFE
K050788 · Everlife Medical Instrument Co., Ltd. · May 2005
BRAINET KIT
K043009 · Jordan Neuroscience, Inc. · Jan 2005
MANTRA ELECTRODE
K041902 · Mantra Intl. (Hk) , Ltd. · Sep 2004
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp · Aug 2004
BIS PEDIATRIC SENSOR
K041670 · Aspect Medical Systems, Inc. · Jul 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · Ambu, Inc. · Mar 2004