Cleared Traditional

K974119 - DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)

K974119 is an FDA 510(k) clearance for DISPOSABLE NEEDLE ELECTRODE (ALM), manufactured by Jack'S Electrodes. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K974119 · Jack'S Electrodes · Neurology device
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Jan 1998
Decision
89d
Days
Class 2
Risk

K974119 is an FDA 510(k) clearance for the DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM). Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Jack'S Electrodes (Altadena, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 Jack'S Electrodes devices

FDA 510(k) Submission Details - K974119

510(k) Number K974119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1997
Decision Date January 28, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 25
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K974119.
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 1999
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · Dantec Medical, Inc. · Mar 1996
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994