Cleared Traditional

K143433 - Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

K143433 is an FDA 510(k) clearance for Dantec DCN Disposable Concentric Needle..., manufactured by Natus Manufacturing Limited. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K143433 · Natus Manufacturing Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
270d
Days
Class 2
Risk

K143433 is an FDA 510(k) clearance for the Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposabl.... Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Natus Manufacturing Limited (Gort, IE). The FDA issued a Cleared decision on August 28, 2015 after a review of 270 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.

View all Natus Manufacturing Limited devices

FDA 510(k) Submission Details - K143433

510(k) Number K143433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date August 28, 2015
Days to Decision 270 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
121d slower than avg
Panel avg: 149d · This submission: 270d
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 40
Devices cleared under the same product code (IKT) and FDA review panel - the closest regulatory comparables to K143433.
Allergan Botox Needle Electrode
K173815 · Natus Manufacturing Limited · Jun 2018
Myoject Luer Lock Needle Electrode
K161430 · Natus Manufacturing Limited · Mar 2017
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
K152984 · Bio Protech, Inc. · Jun 2016
EMG RECORDING ELECTRODE ASSEMBLY
K120342 · Rhythmlink International, LLC · Jun 2012
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
K112034 · Carefusion 209, Inc. · Aug 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
K111131 · Carefusion 209, Inc. · Jun 2011