Cleared Traditional

K981004 - SLE EMG ELECTRODES AND ACCESSORIES

K981004 is an FDA 510(k) clearance for SLE EMG ELECTRODES AND ACCESSORIES, manufactured by Specialized Laboratory Equipment, Ltd.. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K981004 · Specialized Laboratory Equipment, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
217d
Days
Class 2
Risk

K981004 is an FDA 510(k) clearance for the SLE EMG ELECTRODES AND ACCESSORIES. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Specialized Laboratory Equipment, Ltd. (Chico, US). The FDA issued a Cleared decision on October 21, 1998 after a review of 217 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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.

FDA 510(k) Submission Details - K981004

510(k) Number K981004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1998
Decision Date October 21, 1998
Days to Decision 217 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
68d slower than avg
Panel avg: 149d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKT Device Classification - Class 2, Special Controls

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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 - IKT Electrode, Needle, Diagnostic Electromyograph

All 42
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K981004.
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
K982950 · Chalgren Enterprises, Inc. · Jun 1999
ELECTRODE NEEDLES
K990015 · Technomed Europe · May 1999
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25
K990375 · Medtronic Functional Diagnostics A/S · Mar 1999
TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K973442 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997
TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
K973444 · Medelec, Inc. D.B.A. Teca Corp. · Nov 1997
NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
K973529 · Medicotest A/S · Nov 1997
K981004 · SLE EMG ELECTRODES AND ACCESSORIES
Download PDF FDA Summary Specialized Laborator…