Cleared Traditional

K071186 - MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

K071186 is an FDA 510(k) clearance for MODIFICATION TO: AMBU NEUROLINE CONCENT..., manufactured by Ambu A/S. The device is a Class 2 Neurology device with product code IKT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K071186 · Ambu A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
91d
Days
Class 2
Risk

K071186 is an FDA 510(k) clearance for the MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 91 days - within the typical 510(k) review window.

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 - K071186

510(k) Number K071186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date July 30, 2007
Days to Decision 91 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
58d faster than avg
Panel avg: 149d · This submission: 91d
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 K071186.
RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
K091055 · Rhythmlink International, LLC · Jun 2009
RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
K091056 · Rhythmlink International, LLC · Jun 2009
ULTRASHARP CONCENTRIC NEEDLES
K080914 · Rochester Electro Medical, Inc. · Jul 2008
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
K062437 · Technomed Europe · Feb 2007
NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
K020907 · Medicotest A/S · Jun 2002
STERILE EMG ELECTRODES
K011818 · Nicolet Biomedical, Inc. · Sep 2001
K071186 · MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
Download PDF FDA Summary Ambu A/S