Cleared Special

K093825 - AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE

K093825 is an FDA 510(k) clearance for AMBU NEUROLINE DISPOSABLE INOJECT NEEDL..., manufactured by Ambu A/S. The device is a Class 2 Neurology device with product code IKT cleared through the Special 510(k) pathway after a 30-day FDA review.

K093825 · Ambu A/S · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
30d
Days
Class 2
Risk

K093825 is an FDA 510(k) clearance for the AMBU NEUROLINE DISPOSABLE INOJECT 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 January 13, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093825

510(k) Number K093825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date January 13, 2010
Days to Decision 30 days
Submission Type Special
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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K093825.
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DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
K092973 · Bionen S.A.S. · Oct 2010
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
K091410 · Spes Medica Srl · Aug 2009
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
K093825 · AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
Download PDF FDA Summary Ambu A/S