Cleared Traditional

K041902 - MANTRA ELECTRODE

K041902 is an FDA 510(k) clearance for MANTRA ELECTRODE, manufactured by Mantra Intl. (Hk) , Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K041902 · Mantra Intl. (Hk) , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
70d
Days
Class 2
Risk

K041902 is an FDA 510(k) clearance for the MANTRA ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Mantra Intl. (Hk) , Ltd. (Chatsworth, US). The FDA issued a Cleared decision on September 22, 2004 after a review of 70 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 Mantra Intl. (Hk) , Ltd. devices

FDA 510(k) Submission Details - K041902

510(k) Number K041902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2004
Decision Date September 22, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
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 Peers - GXY Electrode, Cutaneous

All 243
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K041902.
RHYTHMLINK DISC ELECTRODES
K061148 · Rhythmlink International, LLC · May 2006
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC · Aug 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
PROTENS ELECTRODE
K042301 · Bio Protech, Inc. · Sep 2004
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp · Aug 2004
BIS PEDIATRIC SENSOR
K041670 · Aspect Medical Systems, Inc. · Jul 2004