Cleared Special

K093825 - AMBU NEUROLINE DISPOSABLE INOJECT NEEDL...

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

K093825 · Ambu A/S · Neurology device
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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.

View all Ambu A/S devices

Submission Details

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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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