Cleared Special

K111131 - TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

K111131 is an FDA 510(k) clearance for TECA (TM) ELITE DISPOSABLE MONOPOLAR NE..., manufactured by Carefusion 209, Inc.. The device is a Class 2 Neurology device with product code IKT cleared through the Special 510(k) pathway after a 57-day FDA review.

K111131 · Carefusion 209, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
57d
Days
Class 2
Risk

K111131 is an FDA 510(k) clearance for the TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Carefusion 209, Inc. (Middleton, US). The FDA issued a Cleared decision on June 17, 2011 after a review of 57 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 - K111131

510(k) Number K111131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2011
Decision Date June 17, 2011
Days to Decision 57 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
92d faster than avg
Panel avg: 149d · This submission: 57d
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 K111131.
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 · Natus Manufacturing Limited · Aug 2015
EMG RECORDING ELECTRODE ASSEMBLY
K120342 · Rhythmlink International, LLC · Jun 2012
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
K112034 · Carefusion 209, Inc. · Aug 2011
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
K092973 · Bionen S.A.S. · Oct 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K093825 · Ambu A/S · Jan 2010
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
K091410 · Spes Medica Srl · Aug 2009
K111131 · TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
Download PDF FDA Summary Carefusion 209, Inc.